MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; SCREW, FIXATION, BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Pma / 510k: this report is for a lag screw/unknown lot; unknown part.Udi number is unknown.Explanted date: device remained in the patient.Complainant part is not expected to be returned for manufacturer review/investigation.The device remained in the patient.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 the interlocking mechanism in a trochanteric fixation nail (tfn) did not lock the lag screw in place and the lag screw kept spinning during a tfn implant for a trochanteric fracture repair on (b)(6) 2017.When the surgeon attempted to lock the lag screw into the tfn, the lag screw did not lock into the locking mechanism and kept spinning.The plan was to implant one (1) tfn, one unknown lag screw and one (1) unknown distal locking screw.The surgeon noted that the lag screw did not lock and decided to insert the lag screw as deep as it would go and conclude the surgery since otherwise, the fracture would have collapsed.The procedure was completed successfully without any surgical delay or any other complications or additional medical interventions.The patient is reported to be stable.This complaint involves two (2) devices.Concomitant devices reported: distal locking screw (part # unknown, lot # unknown, quantity # 1).This report is for a tfn lag screw.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Corrected data: device is a single use device but was not reprocessed or reused.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7159994
• MDR Text Key: 96607003
• Report Number: 2939274-2018-50031
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• 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: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1