MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - INSERTION INSTRUMENTS: CONNECTING/COUPLING SCREW: TRAUMA; MISC ORTHO SURGICAL INSTR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown insertion instruments: connecting/coupling screw/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during a hip surgery, the unknown trochanteric fixation nail advanced lag screw connecting bolt does not attach to the t-handle, for that reason, will not connect to a screw inserter.A new tray was opened to complete the case.There was a 10 minutes surgical delay.The procedure successfully completed.No patient consequence.Concomitant device reported: unk - nail head elem: tfna lag screw (part# unknown; lot# unknown; quantity 1).This complaint involves two (2) devices.This report is for 1 unk - insertion instruments: connecting/coupling screw: trauma.This report is 1 of 2 for (b)(4).

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.Complainant part is not expected to be returned for manufacturer review/investigation.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

09/03/2019: update.It was reported that on (b)(6) 2019, during a hip surgery, the unknown trochanteric fixation nail advanced lag screw connecting bolt did not attach to the screw inserter, as it would not connect to a tfna lag screw.

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: UNK - INSERTION INSTRUMENTS: CONNECTING/COUPLING SCREW: TRAUMA
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8876450
• MDR Text Key: 153955500
• Report Number: 2939274-2019-59618
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Patient Sequence Number: 1