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
Device returned.Occupation: synthes rep.A review of the device history record.Device history lot.Part #: 388.266.Synthes lot number: 4281910.Supplier lot number: 0307.Manufacturing site: synthes (b)(4).Release to warehouse date: 11-jun-2001.Supplier: s.S.White medical products.No ncr¿s were generated during production.Device history batch null, device history 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.Investigation summary background: it was reported on july 17, 2019, during testing at service and repair, the torque limiting wrench was found that this device failed in calibration.There was no patient involvement.This complaint involves one (1) device.Investigation flow: calibration/power tools service and repair evaluation: during service and repair the repair technician reported the device failed in calibration.Torque test failed 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.Visual inspection: the 10 nm torque limiting wrench for 12-point nut (p/n 388.266 lot 4281910 ) was received at customer quality, and it is observed that there is no visual damage which would contribute to the complaint condition.Functional test: the repair technician reported the device failed in calibration.Torque test failed is the reason for repair.The observed condition is not able to be replicated at us cq, however, the complaint condition is confirmed per the service and repair evaluation and attached report.Document/ specification review: 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.Investigation conclusion: the complaint condition is confirmed as the torque wrench (p/n 388.266 lot 4281910) was returned after failing calibration.Visual inspection, document/specification review and functional test were performed as part of this investigation.The complaint condition of ¿failed calibration¿ was confirmed.The returned instrument has exceeded the expected instrument life (three years) established by bradshaw, therefore any recalibration could not be assured.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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) 2019, during testing at service and repair, the torque limiting wrench was found that this device failed in calibration.There was no patient involvement.This complaint involves one (1) device.This report is 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: 9050575
• Report Number: 2939274-2019-60575
• Device Sequence Number: 11310733
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: 4281910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/13/2019
• Patient Sequence Number: 1