MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.130S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date between (b)(6) 2018 and (b)(6) 2018.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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.A device history record review has been requested.(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) 2018 patient underwent removal of the trochanteric fixation nail advance (tfna), that was originally inserted on (b)(6) 2018.It was identified post-operatively, on an unknown date, that the tfna lag screw had not been inserted through the nail.The lag screw was anterior and outside of the nail.On removal of the nail, it was apparent that there were scratches on the outside of the nail where the screw was placed, and a small scratch on the inside through the screw hole.There was a patient consequence reported due to failure of the open reduction internal fixation (orif) procedure.The patient underwent nail removal and total hip arthroplasty.It is unknown if there was a surgical delay.Patient and procedure outcome were unknown.This report is for a titanium (ti) cannulated tfna nail 400mm.This is report 1 of 2 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.H10 additional narrative: h3, h6: manufacturing location: monument; manufacturing date: april 14, 2017; expiration date: march 31, 2027; part: 04.037.130s; 11mm/125 deg ti cann tfna 400mm / right ¿ sterile; lot: h341625 (sterile); lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly instruction met all inspection acceptance criteria.Packaging label log lppf was reviewed and found to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) 13638 supplied by ees (albuquerque) was reviewed and found to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: component parts were not reviewed because the complaint condition was not related to breakage of any component part, therefore, device history record (dhr) review of the raw material(s) would not be relevant to the reported condition.Flow: device interaction/functional & damage: visual (appearance not as expected): visual inspection: upon visual inspection the locking mechanism has been deployed and the nail is scratched/gouged due to an unknown cause.No new issues were identified.Functional test: a functional test could not be performed as the mating part (tfna lag screw) was not returned.Additionally, with the locking mechanism being deployed it would prevent such a test to occur.The reported condition of the lag screw not being inserted into the nail is unable to be confirmed, however the damage to the nail can be confirmed and the complaint condition could not be replicated due to the reasons above.Dimensional inspection: dimensional inspection was not performed as the pertinent features could not be accessed due to the deployed locking mechanism.Document/specification review the following drawing(s) was reviewed; ti cannulated trochanteric fixation nail advanced no design or manufacturing defect or deficiency was observed during the investigation.A device history review, was performed for the returned instrument¿s lot number, and no nonconformance reports (ncrs), no material review reports (mrrs) or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.The complaint is confirmed.Investigation conclusion: based on the available information it is not possible to determine a definitive root cause for the complaint condition.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H11 corrected data: d10.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: 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7974751
• Report Number: 2939274-2018-54428
• Device Sequence Number: 1254944
• Product Code: HSB
• UDI-Device Identifier: 10886982096449
• UDI-Public: (01)10886982096449
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 04.037.130S
• Device Catalogue Number: 04.037.130S
• Device Lot Number: H341625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention