MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.010

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 there was difficulty removing the insertion handle from the trochanteric fixation nail advanced (tfna) nail during a trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2018.The surgeon had to chisel away the top of the connecting screw to get the screw out, which extended the surgery by ten (10) minutes.The patient was reported to be doing fine at the end of the surgery.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 03.037.010, lot# l713166.Manufacturing location: (b)(4), release to warehouse date: mar 13,2018.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The cannulated connecting screw was received with deformation at the hex end recess.The tip of the recess was observed to have been chipped.Additionally, scratches on the surface of the device was observed, which would not contribute to the reported condition.Based on the visual inspection, the complaint is confirmed for deformation to the hex end recess, however the reported complaint condition cannot be confirmed as the mating device was not returned for testing.A functional test could not be replicated at us customer quality as the mating device was not returned.Dimensional analysis was performed after slotting and were within specifications.The outer diameter at the hex end measured at 12.94mm, which is within specifications of 13 0/-0.1mm per the drawing.The hex recess was received with post manufacturing damage; thus, a dimensional analysis is not applicable.Relevant drawings were reviewed during the investigation.While no definitive root cause could be determined, it is possible that the device encountered excessive force/torque when it is being disconnected from the insertion handle/nail, which could contribute to the complaint condition of unable to disassemble from the insertion handle.The reported complaint condition is unconfirmed as the mating device was not returned, however the complaint is confirmed for deformation to the hex recess which would contribute to the complaint condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.

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.Additional narrative: ethnicity: patient ethnicity is unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Corrected data: concomitant medical products.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: CANNULATED CONNECTING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7659079
• MDR Text Key: 113041239
• Report Number: 2939274-2018-52702
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070265
• UDI-Public: (01)10886982070265
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• 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: 06/08/2018

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
• Device Operator: Health Professional
• Device Model Number: 03.037.010
• Device Catalogue Number: 03.037.010
• Device Lot Number: L713166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/13/2018; 08/06/2018
• Supplement Dates FDA Received: 07/26/2018; 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention