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

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

This report is for three (3) unknown unk - screws: 6.5/7.3 mm cannu/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.The complaint indicated that the screw stripped while in patient and could not alter trajectory of screw during procedure.The surgeon changed case from entirely percutaneous to open case via small incision to access pubic symphysis screw.The investigation could not be completed; no conclusion could be drawn, as no product was 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.The complaint indicated that the screw stripped and additional surgical intervention was required.

Event Description

It was reported that on (b)(6) 2019, during open reduction and internal fixation (orif) for percutaneous fixation of pelvic fracture, upon implantation the three (3) screwdriver head of the screwdriver handle and two (2) screwdriver shafts were worn down, causing screw head to strip while in patient and could not alter trajectory of screw during procedure.The three (3) cannulated screws itself do not have a threaded head.The surgeon changed case from entirely percutaneous to open case via small incision to access pubic symphysis screw.There are no fragments generated.Procedure was successfully completed with 30 minutes delayed.Patient status/outcome are unknown.Concomitant device reported: cannulated screws (part # unknown, lot # unknown, quantity 3).This complaint involves six (6) devices.This report is for three (3) unknown unk - screws: 6.5 mm and 7.3 mm cannulated.This report is 3 of 6 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.Device is not expected to be returned for manufacturer review/investigation.Initially reported concomitant devices are not concomitant.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.Part number/lot number is unknown, therefore, physical manufacturer is also unknown.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.

• 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: 8351936
• MDR Text Key: 136602789
• Report Number: 2939274-2019-56523
• 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,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR