MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH QUICK COUPLING, SMALL; TAP, BONE

Catalog Number 311.43

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Visual inspection: the handle with quick coupling, small was received with the end cap component broken off, with a transverse fracture, and missing.There was a vertical crack approximately 8.75 mm in length across the dowel pin.No other issues were identified with the returned components of the device.The device failures/defects of broken handle, missing component, and cracked handle was identified during the investigation and is related to the reported condition of a broken handle.Dimensional inspection: dimensional inspection could not be conducted due to missing component and post manufacturing damage of the handle.Document/specification review: a device history record (dhr) review could not be performed as the lot number is unknown and not etched.The following drawings were reviewed since the exact manufacturing date is unknown.Based on the laser etching and location of the returned device, it was determined that the device was manufactured prior to december 15, 2008.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the handle with quick coupling, small as the end cap component was broken off and missing.There was a vertical crack approximately 8.75 mm in length across the dowel pin.While no definitive root cause could be determined, it is possible that the breakage was due to unintended forces and the broken off end cap was misplaced.The cracked handle condition is likely due to normal wear from consistent handling, use, and reprocessing over its lifetime (10+ years).During this investigation, no product design or manufacturing issues 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.Based on the investigation findings, 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 upon routine inspection of a loaner set at the metro office on an unknown date, one part from the module mini fragment sets was found to be unfit for use; it was the broken handle with quick coupling.There was no patient involvement.This report is for a handle with quick coupling, small.This is report 1 of 1 for (b)(4).

• Brand Name: HANDLE WITH QUICK COUPLING, SMALL
• Type of Device: TAP, BONE
• 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 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8890237
• MDR Text Key: 154410345
• Report Number: 2939274-2019-59813
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: (01)10886982187390
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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