MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM PROTECTION SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.033.007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.The device has been 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) 2020, a couple of pieces of set stuck together, its defective.The sales consultant just received the new set and was putting it together when he noticed.There was no patient involvement.This report is for one (1) 14mm protection sleeve.This is report 2 of 2 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.H3, h4, h6: part 03.033.007-us, lot 63p3516: manufacturing site: hägendorf.Release to warehouse date: september 08, 2020.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: both devices were found to be jammed/ locked.Further observation shows that the blue handle is broken off at the proximal end and it was returned.Both devices were found to be jammed/ locked, could not be disassembled.The complaint is confirmed.The exact cause is unknown.It is likely that excessive force might have applied which caused the broken condition of handle therefore the movable sleeve can no longer be retracted, which may lead to reported failure.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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: 14MM PROTECTION SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10756136
• Report Number: 2939274-2020-04879
• Device Sequence Number: 14376154
• Product Code: LXH
• UDI-Device Identifier: 10886982271112
• UDI-Public: (01)10886982271112
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 03.033.007
• Device Catalogue Number: 03.033.007
• Device Lot Number: 63P3516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1