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

Model Number 388.261

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

It was reported that during testing at service and repair on (b)(6) 2020, 4 10nm torque wrenches were observed to have failed calibration.There was no patient involvement.This is report 1 of 4 for (b)(4).

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.It was reported that during testing at service and repair on (b)(6) 2020, four (4) 10nm torque wrenches were observed to have failed calibration.The repair technician reported the device failed calibration.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.Investigation flow: functional (out of calibration).Visual inspection: 10nm torque wrench 11mm across the flats (part.No: 388.261/ lot.No: 6308901) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the device shows few scratches all over the body which would not contribute to the complaint condition.Functional test: a functional test was performed by service and repair and the repair technician reported the device failed low in calibration.The complaint was able to be replicated therefore the complaint is confirmed.Dimensional inspection: dimensional inspection is not required as the allegation was against the calibration of the device.Document/specification review: the following drawings were reviewed during the investigation: 10n-m torque wrench 11mm width across flats no design issues or discrepancies were noted during the investigation.Complaint confirmed? yes.Investigation conclusion: a visual inspection, and document/specification review were performed as part of this investigation.The complaint is confirmed as the s&r evaluation confirms the calibration issue.The returned instrument has exceeded the expected instrument life (three years) established by s.S.White, therefore any recalibration could not be assured.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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 # 388.261, synthes lot # 6308901, supplier lot # 6308901, release to warehouse date: april 12, 2010, supplier: (b)(4).No ncr's were generated during production.Device history 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.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 WRENCH 11MM ACROSS THE FLATS
• Type of Device: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10391884
• MDR Text Key: 202421900
• Report Number: 2939274-2020-03468
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034772233
• UDI-Public: (01)10705034772233
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

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
• Device Operator: Health Professional
• Device Model Number: 388.261
• Device Catalogue Number: 388.261
• Device Lot Number: 6308901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1