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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part number: 388.266, lot number: h479216-05.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Visual inspection: the 10 nmm torque limiting wrench for 12- point nut (p/n: 388.266, lot #: h479216-05) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that there were scratches on the device and the etch on the device started to fade but have no impact on the functionality of the device.No other issues were observed with the returned components of the device.Functional test: the functional test was performed on the returned device during service and repair evaluation.The min torque of the device measured during calibration testing outside the specified torque range of the device.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 unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint device failed in the calibration test.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.10 nm torque wrench.Complaint confirmed? yes, the device received failed in calibration testing.Hence, confirming the allegation.Investigation conclusion: the complaint condition is confirmed as the 10 nmm torque limiting wrench for 12- point nut (p/n: 388.266, lot # h479216-05) failed low in calibration test.There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.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.
Event or Problem Description
It was reported that on (b)(6) 2020 during testing at service and repair, the torque limiting wrench for 12 point nut failed in calibration.There was no patient involvement.This report is for one 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: 9708237
• Report Number: 2939274-2020-00846
• Device Sequence Number: 16981966
• Product Code: HXC
• UDI-Device Identifier: 10705034772271
• UDI-Public: (01)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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: H479216-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1