MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH 12MM/130 DEG TI CANN TFNA 340MM/RIGHT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.254S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing location: (b)(4).Manufacturing date: 02-oct-2019.Expiration date: 31-aug-2029.Part number: 04.037.254s, 12mm/130 deg ti cann tfna 340mm/right- sterile.Lot number: 17p8602 (sterile).Lot quantity: 3.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16713 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive.Lot number: 16l4953.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: 10l4203.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card were reviewed and determined to be conforming.Lot number 2708390a.Data results were all acceptable.Part number: 04.037.942.2, lock prong, 130 degree tfna.Lot number: 5l55429.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00.Lot number: 12l5386.Lot quantity: (b)(4) lbs.Inspection instruction met all inspection acceptance criteria.Certified test was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Photo investigation: the device was not returned.A photo-investigation was performed on the image.Upon inspecting the image provided, the tfna nail was observed to be broken at the helical blade junction.The complaint condition is confirmed.However, the root cause for the reported event cannot be determined from the available information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the patient was implanted with a trochanteric fixation nail advanced (tfna) to treat a hip fracture.On an unknown date the x-ray showed that it was broken.The patient was revised with a different implant.This report is for one (1) 12mm/130 deg ti cann tfna 340mm/right-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B5 d3 d4 d9 h3, h6: manufacturing location: monument manufacturing date: 02-oct-2019.Expiration date: 31-aug-2029.Part number: 04.037.254s, 12mm/130 deg ti cann tfna 340mm/right- sterile.Lot number: 17p8602 (sterile).Lot quantity: 3.One piece was scrapped in cell at op #50, mill flutes and relief, after a tooling breakage.Two pieces were scrapped in cell at op # 150, qa final inspect, for unacceptable surface finish ¿ dings/scratches.Production order traveler met all inspection acceptance criteria apart from the three pieces noted.Inspection sheet, in-process/inspect dimensional/final, ns071310 rev e met all inspection acceptance criteria apart from the two pieces (surface finish) noted.Inspection sheet, tfna assembly inspection, ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lppf rev d, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16713 supplied by (b)(4)) (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive.Lot number: 16l4953.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, ns062925 rev e met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: 10l4203 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from (b)(4)dated 19-sep-2019 were reviewed and determined to be conforming.Note: material certificate indicates the lot was supplied from (b)(6) lot number 2708390b but sample data sheets indicate lot number 2708390a.Data results were all acceptable.Part number: 04.037.942.2, lock prong, 130 degree tfna lot number: 5l55429 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 12l5386 lot quantity:(b)(4) lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) dated 12-jul-2019 was reviewed and determined to be conforming.Lot summary report dated 12-jul-2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Manufacturing location: monument.Manufacturing date: 02-oct-2019.Expiration date: 31-aug-2029.Part number: 04.037.254s, 12mm/130 deg ti cann tfna 340mm/right- sterile.Lot number: 17p8602 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16713 supplied by (b)(4) (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive.Lot number: 16l4953.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: 10l4203.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card were reviewed and determined to be conforming.Note: material certificate indicates the lot was supplied from (b)(4) lot number 2708390b but sample data sheets indicate lot number 2708390a.Data results were all acceptable.Part number: 04.037.942.2, lock prong, 130 degree tfna lot number: 5l55429 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 12l5386 lot quantity: 1,074 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied was reviewed and determined to be conforming.Lot summary report dated 12-jul-2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the tfna fem nail ø12 r 130° l340 timo15 (p/n: 04.037.254s, lot number: 17p8602) were received at us customer quality (cq) upon visual inspection, the complaint device was broken at the helical blade slot and broken piece was returned.Additionally, scratches from the explantation procedure were observed on the device.No other issues were observed with the returned device.Device failure/defect identified? yes dimensional inspection: complaint relevant dimensional inspection cannot be performed due to post manufacturing damage.Document/specification review: ti cannulated trochanteric fixation nail advanced 130 deg: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed during the investigation.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Visual inspection: the tfna fem nail ø12 r 130° l340 timo15 (p/n: 04.037.254s, lot number: 17p8602) were received at us cq.Upon visual inspection, the complaint device was broken at the helical blade slot and broken piece was returned.Additionally, scratches from the explantation procedure were observed on the device.No other issues were observed with the returned device.Device failure/defect identified? yes.Dimensional inspection: complaint relevant dimensional inspection cannot be performed due to post manufacturing damage.Document/specification review: ti cannulated trochanteric fixation nail advanced 130 deg: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed during the investigation.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Concomitant devices: helical blade (part # 04.038.305, lot # h696789, quantity # 1) unk - screws: nail distal locking (part # unknown, lot # unknown, quantity # 1).

• Brand Name: 12MM/130 DEG TI CANN TFNA 340MM/RIGHT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; muracherstrasse 3; bettlach PA 2544 ; SZ 2544
• MDR Report Key: 12169467
• Report Number: 2939274-2021-04080
• Device Sequence Number: 17089429
• Product Code: HSB
• UDI-Device Identifier: 10886982097347
• UDI-Public: 10886982097347
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.254S
• Device Catalogue Number: 04.037.254S
• Device Lot Number: 17P8602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021; 08/24/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/13/2021; 08/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention