MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER; SCREW,FIXATION,BONE

Model Number	04.005.532S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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 or Problem Description
It was reported that on (b)(6) 2018, patient was implanted with a tfna nail, fenestrated helical blade and distal locking screw for a reverse oblique type intertrochanteric fracture.Post-operative, on (b)(6) 2019, patient was presented to the surgeon with new onset of hip pain.The surgeon reviews the x-rays and observed a non-union of the fracture as well as a broken tfna and distal locking screw.On (b)(6) 2019, patient underwent bone grafting, revision im nailing and hardware removal of a broken trochanteric femoral nail advance (tfna) and distal locking screw.All broken and intact hardware were removed.A new tfna, fenestrated helical blade, traumacem and two (2) locking screws were implanted.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.Concomitant medical products: fenestrated helical blade (part 04.038.395s, lot unknown, quantity 1).This report is for one (1) distal locking screw.This is report 2 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.Visual inspection: actual device not returned.Visual inspection performed at customer quality of complaint file attachment confirmed the condition of post operative screw breakage, which agrees with the reported complaint condition.The screw broke in-situ.A review of the device history records was unable to be performed since the lot number was unknown.Document/specification review: no product design issues or discrepancies were observed during this investigation.Investigation conclusion: a definitive assignable root cause for the screw breaking postoperatively could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and this complaint condition is adequately covered by the risk assessment.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8302552
• Report Number: 2939274-2019-56305
• Device Sequence Number: 64421
• Product Code: HWC
• UDI-Device Identifier: 10886982086013
• UDI-Public: (01)10886982086013
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 04.005.532S
• Device Catalogue Number: 04.005.532S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 03/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 74