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 Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is company representative.Investigation summary: service & repair evaluation: the repair technician reported the device failed in calibration.Torque test failed low is the reason for repair.The cause of the issue is unknown.The device was sent to the vendor for repair on 23- aug-2019.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 & repair history: the previous service event for part number 03.615.040 with lot number(s) h305973-12 has been reviewed.The customer called in a service request for this item on (b)(6) 2019 for failed calibration.The item was previously returned for service on 10-aug-2018 due to failed calibration.The previous service condition of failed calibration is relevant to the current complained issue of failed calibration.The manufacture date of this item is 11-dec-2017.The service history review is confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore 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 july 11, 2019, during evaluation at service and repair it was found out that the torque limiting nut driver failed in calibration.There was no patient involvement.This is report 1 of 1 for (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, h4, h6: the repair technician reported the device failed in calibration.Torque test failed low is the reason for repair.The cause of the issue is unknown.The device was sent to the vendor for repair on 23- aug-2019.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.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.Service & repair history: the previous service event for part number 03.615.040 with lot number(s) h305973-12 has been reviewed.The customer called in a service request for this item on 11-jul-2019 for failed calibration.The item was previously returned for service on 10-aug-2018 due to failed calibration.The previous service condition of failed calibration is relevant to the current complained issue of failed calibration.The manufacture date of this item is 11-dec-2017.The service history review is confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore 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.

• 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: 8969930
• Report Number: 2939274-2019-60357
• Device Sequence Number: 2337000
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 03.615.040
• Device Catalogue Number: 03.615.040
• Device Lot Number: H305973-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1