MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.0MM/4.2MM DRILL SLEEVE 200MM; GUIDE

Model Number	03.010.065
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.A device history record (dhr) review was conducted: device history lot: part # 03.010.065, synthes lot # 4723104, supplier lot # na, release to warehouse date: may 25, 2004, manufactured by synthes (b)(4), no ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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) 2020, during an unknown procedure, during drilling for proximal unknown screws, the drill bit was contacted nail and with an unknown issue.The surgeon successfully passed the unknown screw and after the surgery, the guide/ drill sleeve lined up.It is unknown if there was a surgical delay.The procedure was successfully completed.The patient outcome was unknown.This complaint involves six (6) devices.This report is for (1) 8.0mm/4.2mm drill sleeve 200mm.This is report 2 of 6 for (b)(4).
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.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: 8.0MM/4.2MM DRILL SLEEVE 200MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10285999
• Report Number: 2939274-2020-03233
• Device Sequence Number: 13602290
• Product Code: FZX
• UDI-Device Identifier: 10886982067395
• UDI-Public: (01)10886982067395
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: 03.010.065
• Device Catalogue Number: 03.010.065
• Device Lot Number: 4723104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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: 11MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE; 12.0/8.0MM PRTCTN SLVE W/FLTS FOR SPRAPTLR; 4.2MM 3-FLTED DRL BIT QC/330MM/100MM CLBATN; AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR
• Patient Age: 51 YR