MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING; SCREWDRIVERS

Model Number 321.133

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is company representative.Investigation summary: part # 321.133.Synthes lot # 5021918.Supplier lot # 554839k05.Release to warehouse date: june 24th 2005.Supplier: (b)(4).No non-conformance reports (ncr) were generated during production.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.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.The customer reported the item required calibration testing.The repair technician reported the item failed calibration testing.The cause of the issue is unknown.The item was sent to the vendor for re-calibration.The device will be returned to the customer upon completion of the service and repair process.The device was deemed serviceable and 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 Description

It was reported that on (b)(6) 2019, during testing at service and repair, a torque limiting handle failed in calibration testing.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) torque limiting handle/quick release-6 mm hex coupling.This is report 1 of 1 for (b)(4).

• Brand Name: TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9128940
• MDR Text Key: 160483031
• Report Number: 2939274-2019-60918
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034769110
• UDI-Public: (01)10705034769110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2019

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
• Device Operator: Health Professional
• Device Model Number: 321.133
• Device Catalogue Number: 321.133
• Device Lot Number: 5021918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1