MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 95MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.095S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this 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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent removal/ revision of a broken proximal femoral nailing system (tfna).The patient presented with follow up x-rays that showed the proximal femoral nailing system (tfna) titanium screw backed up and the femoral head rotated.During revision, it was found that the locking gate was broken inside the proximal femoral nailing system (tfna) short nail broke.There were fragments generated from the broken device but everything was removed without a problem.The procedure outcome is unknown.The patient's outcome was a stable revision concomitant device reported: unknown locking screw (part # unknown, lot # unknown, quantity# 1); unknown end cap: tfna (part # unknown, lot # unknown, quantity # 1).This complaint involves two (2) devices.This report is one (1) tfna screw 95mm - sterile.This report is 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.H4, h6: part number: 04.038.095, lot number: h333392, part manufacturing date: april 7, 2017, manufacturing site: elmira, part expiration date: n/a.Nonconformance noted: nr-0067805; no bearing on complaint condition.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h333392 of tfna screws was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h079546 was implicated in nr-0067805 for bent material.This nonconformance has no bearing on the complaint condition, as all affected material was scrapped without being used for finished product.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.

• Brand Name: TFNA SCREW 95MM - 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: 10018229
• Report Number: 2939274-2020-02174
• Device Sequence Number: 16886031
• Product Code: HSB
• UDI-Device Identifier: 10886982098498
• UDI-Public: (01)10886982098498
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 04.038.095S
• Device Catalogue Number: 04.038.095S
• Device Lot Number: H333392
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/15/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/130 DEG TI CANN TFNA 170MM - STERILE; TFNA SCREW 95MM - STERILE; TFNA SCREW 95MM - STERILE; UNK - END CAPS: TFNA; UNK - END CAPS: TFNA; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention