MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.045S

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from synthes, reports an event in (b)(6) as follows: it was reported that, on (b)(6) 2019, the patient had to go through a revision surgery due to tfna nail breakage & nonunion.Tfna nail broke from the junction of blade/screw insertion (bump cut design point in nail).First tfna nailing was done on this patient 3 months back.Nail breakdown results in nonunion/ malunion & revision surgery & also increases the risk of infection.Revision surgery was also performed because of nail breakage today.Concomitant device reported: unknown lag screw (part #: unknown, lot #: unknown, quantity: 1), unknown locking screw (part #: unknown, lot #: unknown, quantity: 1).This complaint involves one (1) device.This report is for one (1) 10mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for pc (b)(4).

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.H3, h4, h6: manufacturing location: monument manufacturing date: july 10, 2018, expiration date: june 01, 2028, part: 04.037.045s, 10mm/130 deg ti cann tfna 235mm/left ¿ sterile, lot: h676472 (sterile).One piece was scrapped.The remainder of the lot was 100% inspected and determined to be conforming.Work order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in process / inspect dimensional / final met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Sterilization control number (scn) supplied by ees (albuquerque) 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: 04.037.942.2, lock prong, 130 degree, tfna bp55 lot: l851022.One piece was scrapped.Purchased finished goods traveler met all inspection acceptance criteria apart from the one piece noted.Part: 04.037.912.4, wave spring, shim ended bp55 lot: h571510 work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by smalley were reviewed and determined to be conforming.Part: 04.037.912.3, tfna lock drive bp58 lot: h656363.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part: 21127, timoagri16.00 bp80 lot: h637306.Certificate of analysis supplied by metalwerks inc.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.Reviewing the provided x-ray, the complaint description can be confirmed that the tfna nail broke in the area of tfna blade bore hole.Visual inspection: the tfna fem nail dia 10 le 130 degree ls35 timo 15 was returned and receives at us customer quality (cq).Upon visual inspection, it was observed that the device was broken through the walls of the helical blade opening of the nail.There were scratches on the device which are consistent from explantation and have no impact on the functionality of the device.Dimensional inspection: the outer diameter of both the broken parts of the received device was measured to be within the specification per drawing.Document/specification review: based on the date of manufacture, the following drawings, reflecting the current and manufactured revision were reviewed: 10mm ti cannulated trochanteric femoral nail-advanced 235 mm ti cannulated trochanteric fixation nail 130 deg investigation conclusion the complaint condition is confirmed for the tfna fem nail dia 10 le 130 degree ls35 timo 15.There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.H6: code 3191 is also being used to capture non-union of fracture and malunion of fracture.B3: date of event is an unknown date in 2019.H6 - patient codes: codes 1870 and 2369 were incorrectly applied to the initial report.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.

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.Manufacturing location: monument manufacturing date: july 10, 2018, expiration date: june 1, 2028, part number: 04.037.045s, 10mm/130 deg ti cann tfna 235mm/left ¿ sterile, lot number: h676472 (sterile), lot quantity: 5.One piece was scrapped in cell at op #20, mill id, for an undersized slot.The remainder of the lot was 100% inspected for this feature and determined to be conforming.Work order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in process / inspect dimensional / final met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) lmd 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: 04.037.942.2, lock prong, 130 degree, tfna bp55, lot number: l851022, lot quantity: 95.One piece was scrapped in cell at op #30, thermal rinse-load, after being dropped.Purchased finished goods traveler met all inspection acceptance criteria apart from the one piece noted.Part number: 04.037.912.4, wave spring, shim ended bp55, lot number: h571510, lot quantity: 1,000.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by smalley dated may 29, 2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive bp58, lot number: h656363, lot quantity: 80.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 21127, timoagri16.00 bp80, lot number: h637306, lot quantity: 2,803 lbs.Lot quantity: 2,626 lbs.Certificate of analysis supplied by metalwerks inc.Dated april 20, 2018 was reviewed and determined to be conforming.Lot summary report dated may 4, 2018 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 dia 10 le 130 degree ls35 timo 15 (p/n: 04.037.045s, lot #: h676472) was returned and receives at us customer quality (cq).Upon visual inspection, it was observed that the device was broken through the walls of the helical blade opening of the nail.There were scratches on the device likely due to the implantation and explantation which have no impact on the functionality of the device.Device failure/defect identified? yes.Dimensional inspection: the outer diameter of both the broken parts of the received device was measured to be 15.65 mm (ca 802).This is within the specification.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed -10mm ti cannulated trochanteric femoral nail-advanced 235 mm, -ti cannulated trochanteric fixation nail 130 deg.Complaint confirmed? yes, the received device was broken.Hence confirming the complaint.Investigation conclusion the complaint condition is confirmed for the tfna fem nail dia 10 le 130 degree ls35 timo 15 (p/n: 04.037.045s, lot #: h676472).There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.Pie and pia was launched previous to this complaint to investigate tfna nail breakage and associated drill marks/damage at the head element hole/blade aperture.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: 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9496400
• MDR Text Key: 188050529
• Report Number: 8030965-2019-71266
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649972
• UDI-Public: (01)07611819649972
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.045S
• Device Lot Number: H676472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2020
• Date Manufacturer Received: 05/20/2020
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - SCREWS: LOCKING
• Patient Age: 76 YR