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

Model Number	03.010.065
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that on (b)(6) 2020, during an unknown procedure, while drilling, the surgeon hit the nail and devices (insertion handle, cannulated screw, protection sleeve, drill sleeve, aiming arm for supratellar, titanium cannulated tibial nail, and drill bit) did not line up completely.The procedure was successfully completed with no surgical delay.No patient consequences.This complaint involves seven (7) devices.This is report 4 of 7 for (b)(4).
Event or Problem Description
Concomitant devices reported: nail (part unknown, lot unknown, quantity 1).
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.H3, h4, h6: part 03.010.065, lot 4723104: manufacturing site: synthes brandywine.Release to warehouse date: may 25, 2004.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.H3, h6: a product investigation was completed: upon visual inspection it was noticed that not all the reported devices were returned for possible functional verification.There were no defects noticed on the device itself.Not all the mating devices were returned, but the returned devices were put together and there was no issue in the interaction of the devices.The overall functional test was not performed as the mating devices were not returned.Dimensional inspection showed the relevant dimensions were conforming.The current and manufactured to drawings were reviewed.The complaint condition is not confirmed for the returned part.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11078231
• Report Number: 2939274-2020-05726
• Device Sequence Number: 11506961
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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/375MM-STERILE; 12.0MM/8.0MM PROTECTION SLEEVE 188MM; AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - NAILS; 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE; 12.0MM/8.0MM PROTECTION SLEEVE 188MM; AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR
• Patient Age: 29 YR