MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM; NAIL, FIXATION, BONE

Model Number 212.104

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Patient age/date of birth and weight are unknown.(b)(4).Due to intra-operative issues, the device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

It was reported that on (b)(6) 2018 during an unknown procedure, an 8-hole 1/3 tubular plate was placed on the patient's distal fibula.After drilling through the drill guide, the locking screw would not lock into the plate.The surgeon tried another screw and the screw locked in.The patient outcome was stable and the procedure was successfully completed.There was a four (4) minute surgical delay and was no patient consequence reported.No other additional information available.Concomitant device: unknown drill guide (part unknown, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: visual inspection performed showed no wear or damage or abnormalities to the returned screw when viewed under 10x magnification.A functional test in effort to replicate the reported complaint condition was not able to be performed because the plate involved in the event was not returned.The reported complaint condition of the screw not locking to the plate was not able to be confirmed or replicated.A review of the device history records was unable to be performed since the lot number was unknown.Relevant drawings for the family of 3.5mm locking screws was reviewed during this investigation.No product design issues or discrepancies were observed.The peak major diameter (most proximal) of the returned locking screw head was measured and was within specification.The major thread diameter of the returned locking screw shaft was measured and was within specification.A definitive root cause for the reported complaint condition could not be determined based on the provided information.It is possible that the screw was not aligned perpendicular to the plate hole thread during attempted insertion.This complaint was not able to be confirmed and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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.

Event Description

Concomitant device: unknown drill guide (part: unknown, lot: unknown, quantity: 1), locking compression plate (lcp) cloverleaf 3.5mm 3-hole sst (part: 241.831, lot: unknown, quantity: 1).

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.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: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7531330
• MDR Text Key: 108863637
• Report Number: 2939274-2018-52248
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982151780
• UDI-Public: (01)10886982151780
• Combination Product (y/n): N
• PMA/PMN Number: K072095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212.104
• Device Catalogue Number: 212.104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1