MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 105MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.205S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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.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 on (b)(6) 2019 the patient underwent revision due to the trochanteric fixation nail advance (tfna) lag screw migrated outside the nail medially.The lag screw presented as medial and completely outside of the tfna nail.The lag screw migrated medial through both the femoral head and the acetabulum.All of the device construct was removed.The initial surgery was completed on (b)(6) 2019.It was unknown if there was a surgical delay.Procedure was successfully completed.Patient outcome was unknown.Concomitant devices reported: unknown tfna nail (part # unknown, lot # unknown, quantity #: unknown), unknown locking screw (part #: 04.005.040, lot #: unknown, quantity #: 5).This complaint involves one (1) device.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
A new tfna construct was implanted successfully.(b)(4) captures the second lag screw that was removed and (b)(4) captures the first lag screw that was removed.
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.Date of event: event year reported as 2019; however exact date of postoperative screw migration is unknown.A device history record (dhr) review was conducted: part number: 04.038.205s, lot number: h737070, part manufacturing date: 03 october 2018, manufacturing site: elmira, part expiration date: 31 august 2028, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h737070 of tfna fenestrated 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 h618479 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.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 FENESTRATED SCREW 105MM - 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: 8400795
• Report Number: 2939274-2019-56864
• Device Sequence Number: 253137
• Product Code: HSB
• UDI-Device Identifier: 10886982098795
• UDI-Public: (01)10886982098795
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2019

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: 04.038.205S
• Device Catalogue Number: 04.038.205S
• Device Lot Number: H737070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 04/26/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/24/2019; 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1