MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BALL HEX SCREWDRIVER 8MM; SCREWDRIVERS

Catalog Number	03.010.092
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient ethnicity is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(b)(4).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 or Problem Description
It was reported that during a suprapatellar procedure on (b)(6) 2018, a tibial nail was inserted using the suprapatellar instrumentation.After placing a proximal locking screw in the dynamic hole of the tibial nail, they attempted to remove the insertion handle.They could only get the connecting screw to turn a little.They ended up breaking the tip of the ball hex screwdriver in their efforts to get the connecting screw out.Fragments were generated but were removed easily without additional intervention.They decided to remove the proximal locking screw and pull the tibial nail out.A different instrumentation set was used, and a new tibial nail was inserted.The same proximal locking screw was reinserted in the new tibial nail and the distal locking screws were then completed.The procedure was completed successfully with a 40-minute surgical delay.The patient outcome was good.Concomitant device: proximal locking screw 4x44mm (part: unknown, lot: unknown, quantity: 1), insertion handle for suprapatellar (part: 03.010.440, lot: 07611819447, quantity: 1).This report is for a ball hex screwdriver 8mm.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Part/lot combination are unknown at synthes gmbh, no dhr review possible.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.
Additional 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.Corrected lot number of concomitant device 03.010.440.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 or Problem Description
Concomitant device: proximal locking screw 4x44mm (part: unknown, lot: unknown, quantity: 1), insertion handle for suprapatellar (part: 03.010.440, lot: 170125-101, quantity: 1).

• Brand Name: BALL HEX SCREWDRIVER 8MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7782192
• Report Number: 2939274-2018-53322
• Device Sequence Number: 1012600
• Product Code: HXX
• UDI-Device Identifier: 10886982067630
• UDI-Public: (01)10886982067630
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.092
• Device Lot Number: 3800515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 08/28/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/13/2018; 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: JULY 27, 2018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 100