MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC XRL MEDIUM TORQUE LIMITING HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	03.807.357
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.Investigation summary: investigation flow: power tools/calibration.Visual inspection: the xrl medium torque limiting handle (p/n: 03.807.357, lot #: 1019) was returned and received at us customer quality (cq).Upon visual inspection, no issues were identified with the returned device.Functional test: a functional test was performed on the returned device at service and repair.The lowest torque of the device measured during calibration testing was 0.53 nm which was not within the specified torque range of the device of 0.55 nm - 1.0 nm.Hence, the torque test failed low.Service & repair history: the previous service event for part number 03.807.357 with lot number(s) 1019 has been reviewed.The customer called in a service request for this item on aug 12, 2020 for failed in calibration.The item was previously returned for service on june 29, 2016 due to tested ok.The previous service condition of tested ok is not relevant to the current complained issue of failed in calibration.The manufacture date of this item is dec 1, 2011.The service history review is unconfirmed.Service & repair evaluation: the customer reported the device failed calibration.The repair technician reported the device failed low.Torque test low is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is failed low.The item will be forwarded to customer quality.The evaluation was confirmed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed torque limiting driver: 03_807_359, rev.G/d complaint confirmed? yes, the device received failed low in torque test.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the xrl medium torque limiting handle (p/n: 03.807.357, lot #: 1019).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to device maintenance.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 history lot: part number: 03.807.357, lot number: 1019, per service and repair history, manufactured date: dec 1, 2011.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 testing at service and repair, a xrl medium torque limiting handle failed in calibration.There was no patient involvement.This report is for one (1) xrl medium torque limiting handle.This is report 1 of 1 for (b)(4).

• Brand Name: XRL MEDIUM TORQUE LIMITING HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10511416
• Report Number: 2939274-2020-04065
• Device Sequence Number: 11521286
• Product Code: LXH
• UDI-Device Identifier: 10705034723303
• UDI-Public: (01)10705034723303
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/12/2020

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: 03.807.357
• Device Catalogue Number: 03.807.357
• Device Lot Number: 1019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1