MAUDE Adverse Event Report: SYNTHES GMBH 14/130 DEG TI CANN TFNA 380/RIGHT-SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.458S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, the tfna nail broke inside the patient.It is unknown when the issue was discovered.No other information was provided.This report is for one (1) 14/130 deg ti cann tfna 380/right-sile.This is report 1 of 3 for complaint (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.H10 additional narrative: e3: reporter is a j&j employee.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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.H6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo/x-ray investigation revealed that there was a nail and screw construct implanted at the right femur.It was observed that the tfna was broken proximally at the intersection with the helical blade.Based on the provided evidence, the investigation was able to confirm the reported event.No other problem identified.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the device would contribute to the complained device issue.Based on the investigation findings, the potential cause was attributed to component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H6: device history record (dhr) review conducted: manufacturing location: monument, manufacturing date: 11-dec-2022, expiration date: 30-nov-2032, part number: 04.037.458s, 14mm/130 deg ti cann tfna 380mm/right-sterile, lot number: 3485p17 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection certificate 04.037.450s-11-btq899596 / 1 met all inspection acceptance criteria.Packaging label log (pll) lppf was reviewed and determined to be conforming.Scn 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: 3173p12 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria apart from 5 pieces scrapped at op50, final inspection for surface finish-dings/scratches.Inspection sheet, met all inspection acceptance criteria apart from the 5 pieces noted.Part number: 04.037.942.2, lock prong, 130 degree, tfna static locking pron lot number: 3356p39 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 2002p52 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report dated 23-aug-2022 was reviewed and determined to be conforming.Lot summary report dated 14-nov-2022 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.

• Brand Name: 14/130 DEG TI CANN TFNA 380/RIGHT-SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18885849
• Report Number: 8030965-2024-03531
• Device Sequence Number: 12647307
• Product Code: HSB
• UDI-Device Identifier: 10886982097620
• UDI-Public: (01)10886982097620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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 Catalogue Number: 04.037.458S
• Device Lot Number: 3485P17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 100 -S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown