MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC XRL MEDIUM TORQUE LIMITING HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.807.357
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a j&j employee.The subject 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 on an unknown date, during routine incoming inspection of a loaner set, it was observed that the xrl medium torque limiting handle was found to be out of drawing specification.There was no known patient or hospital involvement.This report is for one (1) xrl medium torque limiting handle this is report 1 of 1 for complaint (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.Part: 03.807.357.Lot: 1279.Manufacturing site: oberdorf.Supplier: n/a.Release to warehouse date: may 9, 2015.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The item passed testing per the inspection sheet and worked within normal parameters.The complained issue was not able to be reproduced.The cause of the complained issue is unknown.The item passed synthes final inspection and will be returned to the customer upon completion of the service and repair process.The evaluation was unconfirmed.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: XRL MEDIUM TORQUE LIMITING HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13762232
• Report Number: 2939274-2022-00875
• Device Sequence Number: 19462545
• Product Code: LXH
• UDI-Device Identifier: 10705034723303
• UDI-Public: (01)10705034723303
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 03.807.357
• Device Catalogue Number: 03.807.357
• Device Lot Number: 1279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown