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 j&j employee.Investigation summary: visual inspection: the 10 nm torque limiting wrench for 12 point nut (p/n: 388.266, lot #: 4271208) was returned and received at us cq.Upon visual inspection, no issues were identified with the returned device.Functional test: a functional test was performed at service and repair evaluation.The low torque of the device was measured to be 9.95 nm.This is not within the specification of 10 nm -11 nm per (b)(4).Service and repair evaluation: during evaluation at service and repair, the 10nm torque limiting wrench for 12-point nut was found to have failed calibration.The repair technician reported that there is adhesive residue on tip of chuck, unable to remove.Torque test low is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.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: loaner set product-specific inspection and verification instructions, 10 n.M torque wrench.Complaint confirmed? yes, the device received failed low in calibration.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the 10 nm torque limiting wrench for 12 point nut (p/n: 388.266, lot #: 4271208).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: 388.266, synthes lot number: 4271208, supplier lot number: n/a, release to warehouse date: may 10, 2001, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Device history review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 (b)(6) 2020, during evaluation at service and repair, the 10nm torque limiting wrench for 12-point nut was found to have failed calibration.There was no patient involvement.This report is for one (1) 10nm torque limiting wrench for 12-point nut.This is report 1 of 1 for (b)(4).

• 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: 11097562
• Report Number: 2939274-2020-05774
• Device Sequence Number: 3922742
• 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
• Report Date (Section B): 12/02/2020

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: 388.266
• Device Catalogue Number: 388.266
• Device Lot Number: 4271208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1