MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5NM TORQUE LIMITING NUT DRIVER; SCREWDRIVERS

Model Number	03.615.040
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 synthes employee.The device has been 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 or Problem Description
It was reported that on (b)(6) 2020, during testing at service and repair, the 2.5nm torque limiter for locking nut failed in calibration.There was no patient involvement.This report is for one (1) 2.5nm torque limiting nut driver.This is report 1 of 1 for complaint (b)(4).
Additional 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.H3, h6: a product investigation was conducted.Synthes service and repair evaluation: the customer reported the device failed in calibration.The repair technician reported the device failed high in calibration.The cause of the issue is failed high.The device was sent to the vendor for repair on 24-jan-2020.The vendor will repair the device per the vendor work instructions.The device will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 21.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.Service history: the previous service event for part number 03.615.040 with lot number(s) 9831909-15 has been reviewed.The customer called in a service request for this item on 8-jan-2020 for locking nut failed in calibration.The item was previously returned for service on 7-mar-2018 due to out of calibration.The previous service condition of out of calibration is relevant to the current complained issue of locking nut failed in calibration.The manufacture date of this item is 8-aug-2017.The service history review is confirmed.Us customer quality returned product investigation flow: power tools/calibration.Functional test below provided by tecomet.See attachment "tecomet 03.615.040 lot 9831909-15".Visual inspection: the returned 2.5nm torque limiting nut driver (p/n: 03.615.040, lot #: 9831909-15) displayed no damage or defect.Functional test: torque testing revealed the device's torque was too high; the device was able to be re-calibrated and returned to the customer.Document/specification review: the relevant manufactured-to/current engineering drawing was review during investigation; no design issues were revealed during investigation.Investigation conclusion: the complaint condition was confirmed.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies 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.Therefore, it has been determined that no corrective and/or preventive 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.

• Brand Name: 2.5NM TORQUE LIMITING NUT DRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9639221
• Report Number: 2939274-2020-00485
• Device Sequence Number: 14181236
• Product Code: HXX
• UDI-Device Identifier: 10705034715339
• UDI-Public: (01)10705034715339
• 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,Followup
• Report Date (Section B): 01/08/2020

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: 03.615.040
• Device Catalogue Number: 03.615.040
• Device Lot Number: 9831909-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1