MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MINI QUICK COUPLING CHUCK; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	310.90
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, 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 or Problem Description
It was reported that on (b)(6) 2019, the screwdriver shaft was broken and stuck in the mini quick coupling chuck while removing a screw.The mini quick coupling chuck could not be used and was damaged.A stardrive screwdriver shaft t8 was used to remove the rest of the screws.There was no surgical delay.Procedure was successfully completed.Patient status was stable.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) mini quick coupling chuck.This is report 2 of 2 for (b)(4).This complaint captures the intra-operative event while (b)(4) captures the post-operative event.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.(b)(6) 2019: the initial complaint mwr-26032019-0000380318, for ip-00518680 was reviewed and found not reportable.This device is a power tools device and is being reported and captured on complaint (b)(4).

• Brand Name: MINI QUICK COUPLING CHUCK
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8480166
• Report Number: 2939274-2019-57256
• Device Sequence Number: 13718648
• Product Code: HWE
• UDI-Device Identifier: 10886982187079
• UDI-Public: (01)10886982187079
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 310.90
• Device Catalogue Number: 310.90
• Device Lot Number: L415212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 107