MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10NM TORQUE WRENCH 11MM ACROSS THE FLATS

Model Number	388.261
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.Part number: 388.261, lot number: 6556409.Per service history, the manufacture date of this item is 02-mar-2011.Visual inspection: the 10 nm torque wrench 11 mm across the flats (p/n: 388.261, lot #: 6556409) was returned and received at us customer quality (cq).Upon visual inspection, no issues were observed with the returned device.Functional test: a functional test was performed on the returned device at service and repair.The highest torque of the device measured during calibration testing was not within the specified torque range of the device.Hence, the torque test failed high.Service and repair evaluation: during evaluation at service and repair, the 10nm torque wrench was found to have failed calibration.The repair technician reported one of the device failed high.Torque test high 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.Service & repair history: the previous service event for part number 388.261 with lot number(s) 6556409 has been reviewed.The customer called in a service request for this item on 12-apr-2021 for failed calibration.The item was previously returned for service on 9-sep-2015 due to tested ok.The previous service condition of tested ok is not relevant to the current complained issue of failed calibration.The manufacture date of this item is 2-mar-2011.The service history review is unconfirmed.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed synthes loaner set product specific inspection and verification instructions, 10 n-m torque wrench.Complaint confirmed? yes, the device received failed high.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the 10 nm torque wrench 11 mm across the flats (p/n: 388.261, lot #: 6556409).There is no indication that a design or manufacturing issue has caused the complaint condition 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 april 12, 2021, during evaluation at service and repair, the 10nm torque wrench was found to have failed calibration.There was no patient involvement.This report is for one (1) 10nm torque wrench 11mm across the flats.This is report 1 of 1 for (b)(4).

• Brand Name: 10NM TORQUE WRENCH 11MM ACROSS THE FLATS
• Common Device Name: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11784885
• Report Number: 2939274-2021-02242
• Device Sequence Number: 3201910
• Product Code: HXC
• UDI-Device Identifier: 10705034772233
• UDI-Public: 10705034772233
• 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): 04/12/2021

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: 388.261
• Device Catalogue Number: 388.261
• Device Lot Number: 6556409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1