MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 80MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.570S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Lot number is unknown.Explanted date: device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a distal interlock did not align with the nail as expected.The issue happened during a retrograde femoral nail surgery on (b)(6) 2018.The issue was noticed when the surgeon took the final x-rays.It was then found that the screw did not go through the nail.The surgeon made the decision to move the device and manually screw it through the nail, causing a 30-minute delay.The patient was stable following the surgery.Concomitant products: aiming arm for retrograde standard locking (part 03.010.050, lot unknown, quantity 1), cannulated connecting screw for standard insertion handle (part 03.010.444, lot unknown, quantity 1), and a tibial nail (part/lot unknown, quantity 1).This report is for a 5.0mm ti locking screw w/t25 stardrive 80mm f/im nail-ster.This is report 3 of 3 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.Lot number, expiration date: this information is now known.This information is now known.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.
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.Item: 04.005.570s; lot: h263900; mfg qty: 152; mfg date: january 10, 2017; mfg location: monument; scn: 13328; exp date: november 30, 2025; product was inspected and passed.Product was packaged.There were no nonconformance reports (ncrs) or reworks generated during the manufacture of this lot.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product 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: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 80MM 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: 7503265
• Report Number: 2939274-2018-52128
• Device Sequence Number: 184604
• Product Code: HWC
• UDI-Device Identifier: 10886982086396
• UDI-Public: (01)10886982086396
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2018

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 Expiration Date: 11/30/2025
• Device Model Number: 04.005.570S
• Device Catalogue Number: 04.005.570S
• Device Lot Number: H263900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 06/12/2018; 06/14/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/13/2018; 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR