MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE WITH LOCKING DEVICE; SCREWDRIVER

Model Number	03.010.112
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2021, while inserting an unknown distal interlocking screw on a humeral nail, the surgeon attempted to use a screw retaining sleeve.The screw retaining sleeve did not function correctly and was unable to be used.The surgeon had difficulty inserting this screw because of the unavailability of the retaining sleeve.The screw was ultimately inserted and the surgery was completed successfully.No fragments generated.There were a 10 minutes surgical delay.No patient consequence.Concomitant device reported: unk - screws: nail distal locking (part# unknown; lot# unknown; quantity: unknown) unk - nails: humeral (part# unknown; lot# unknown; quantity: unknown).This complaint involves (1) device.This report is 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: part # 03.010.112.Synthes lot # 5304923.Supplier lot # na.Release to warehouse date: october 23, 2006.Manufactured by synthes brandywine.No ncr's were generated during production.Visual inspection: the holding sleeve with locking device (part #: 03.010.112, lot #: 5304923) was received at us customer quality (cq).Visual inspection of the complaint device showed no defect.Functional test: during functional assessment, the device was disassembled and all components were inspected.No missing component was noticed.The components were re-assembled back together.Component (6), of the drawing, the captivation nut was tighten but not all the way.A 7.22mm gage pin was used as screw head.The captivation nut was pressed which allowed the collet, component (1) to advance allowing the jaws to opened up.The jaws closed back on the pin gage after the pressure was released on the captivation nut.The captivation nut was then tighten to hold firmly the pin gage.With this simulation, the device performed as intended and no issue was observed during functional assessment.Can the complaint be replicated with the returned device? no.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as the no defect was observed that could impact the functionality of the device.The device passed the functional assessment.No root cause could definitively be determined for the reported complaint condition.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.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.G1: manufacturing site name and address.

• Brand Name: HOLDING SLEEVE WITH LOCKING DEVICE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12096158
• Report Number: 2939274-2021-03339
• Device Sequence Number: 11803881
• Product Code: HXX
• UDI-Device Identifier: 10886982067845
• UDI-Public: (01)10886982067845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/08/2021

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: 03.010.112
• Device Catalogue Number: 03.010.112
• Device Lot Number: 5304923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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: UNK - NAILS: HUMERAL; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - NAILS: HUMERAL; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Age: 31 YR
• Patient Weight: 81