MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-HANDLE BALL HEX SCREWDRIVER 8MM

Model Number 03.010.517

Device Problem Device-Device Incompatibility (2919)

Patient Problem Injury (2348)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2020, after devices were implanted, the surgeon had difficulty removing the insertion handle from the nail.The surgeon was unable to remove the connecting screw using the ballhex screwdriver from the nail.The surgeon completely removed the nail and put on a smith and nephew nail.The procedure was completed successfully.Patient status is unknown.Concomitant devices reported: insertion handle for suprapatellar (part number 03.010.440, lot 180183-101, quantity 1), cann connecting scr f/percutan instruments for nails-ex (part number 03.010.404, lot u329528, quantity 1), 9mm ti cann tibial nail-ex w/prox bend 345mm-sterile (part number 04.034.349, lot h602848, quantity 1).This report involves one (1) t-handle ball hex screwdriver 8mm.This is report 3 of 4 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.H10 additional narrative: e1: initial reporter information updated.H3, h4, h6: the complaint product is not available to return for investigation.The customer retaining the product.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: T-HANDLE BALL HEX SCREWDRIVER 8MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10579780
• MDR Text Key: 208321464
• Report Number: 2939274-2020-04294
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982069306
• UDI-Public: (01)10886982069306
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

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: 03.010.517
• Device Catalogue Number: 03.010.517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9MM TI CANN TIBIAL NAIL.; CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS.; INSERTION HANDLE FOR SUPRAPATELLAR.; 9MM TI CANN TIBIAL NAIL; CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS; INSERTION HANDLE FOR SUPRAPATELLAR
• Patient Outcome(s): Required Intervention