MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC XRL LARGE TORQUE LIMITING HANDLE; SURGICAL, MISC. ORTHO, INSTRUMENT

Model Number	03.807.358
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: synthe rep.A review of the device history record: device history lot.Part: 03.807.358.Serial number: (b)(4).Manufacturing site: (b)(4).Release to warehouse date: 26.May 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary complaint summary: it was reported that on july 17, 2019, during testing at service and repair, a torque limiting handle failed in calibration.There was no patient involvement.This complaint involves one (1) device.Service & repair history: the previous service event for part number 03.807.358 with lot number 1105 has been reviewed.The customer called in a service request for this item on (b)(6) 2019 for failure of calibration.The item was previously returned for service on 26-may-2016 for the same reason.The previous service condition of is relevant to the current complained issue of calibration.The manufacture date of this item is 02-jul-2016.The service history review is confirmed.Service & 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.Flow: power tools/calibration.Visual inspection: the xrl large torque limiting handle (p/n 03.807.358 s/n 1105) was received at customer quality, and it is observed that there is no visual damage except a few scratches which would not contribute to the complaint condition.Functional test: functional testing was completed during service evaluation.During the service evaluation the device was found to register a minimum torque value and the device fell lower than the low end of the allowable torque range on 3 of the 24 tests.During investigation, it was observed that the upper torque limit for both the medium (03.807.357) and large (03.807.358) xrl torque limiting handles, were expanded.Torque limiting driver synex rl small: 03_807_359 rev d.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint condition is confirmed as the xrl large torque limiting handle (p/n 03.807.358 s/n 1105) 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.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.No new product design or manufacturing issues were identified during this investigation and therefore no additional 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.Relevant actions have been taken to address the issue.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 july 17, 2019, during testing at service and repair, a torque limiting handle 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: XRL LARGE TORQUE LIMITING HANDLE
• Common Device Name: SURGICAL, MISC. ORTHO, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9069795
• Report Number: 2939274-2019-60571
• Device Sequence Number: 3761969
• Product Code: LXH
• UDI-Device Identifier: 10705034723310
• UDI-Public: (01)10705034723310
• 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): 08/27/2019

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: 03.807.358
• Device Catalogue Number: 03.807.358
• Device Lot Number: 1105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/16/2019
• Patient Sequence Number: 1