MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10NM TORQUE LIMITING WRENCH FOR 12-POINT NUT

Model Number	388.266
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
Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 an unknown date that the torque wrench failed calibration.This report is for 1 10nm torque limiting wrench for 12-point nut.This is report 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.H10: additional narrative: h3, h4, h6: part 388.266, lot h153380-08: release to warehouse date: june 14, 2017.Supplier: (b)(4) no non-conformance reports (ncr's) were generated during production.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 service and repair evaluation was complete: the repair technician reported the device had a low torque test.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.H3, h6: a product investigation was completed: visual inspection of the complaint device showed some minor cosmetic external scratches that would not contribute to the complaint condition.A functional assessment was performed on the complaint device at service and repair.The complaint device torque tested low.The complaint was able to be replicated.A functional assessment was performed on the complaint device at service and repair.The complaint device torque tested low.The complaint was able to be replicated.The current and manufactured to drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as the device torque tested low.The device also has some minor cosmetic scratches.No definitive root cause could be determined based on the provided information.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 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: 10NM TORQUE LIMITING WRENCH FOR 12-POINT NUT
• Common Device Name: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11022447
• Report Number: 2939274-2020-05616
• Device Sequence Number: 11861178
• Product Code: HXC
• UDI-Device Identifier: 10705034772271
• UDI-Public: 10705034772271
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 388.266
• Device Catalogue Number: 388.266
• Device Lot Number: H153380-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1