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.Device history record (dhr) review could not be performed since the lot number is unknown.Visual inspection: the handle with quick coupling, small was received with the end cap component fallen off from the handle.The end cap is press fit onto the handle during manufacturing.No other issues were identified with the returned components of the device.Functional inspection: functional testing showed that the end cap was able to fit onto the handle, however, it would not stay on due to warpage of the press fit features.The complaint can be replicated with the returned device.Dimensional inspection: dimensional inspection could not be conducted due to warpage of the press fit features.Document/specification review: a dhr review could not be performed as the lot number is unknown and not etched.Device drawings were reviewed.Based on the design drawing laser etching, revision a changed the laser etching to include lot number and changed the location of the etchings to the sleeve.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 had fallen off from the handle and would not stay on due to warpage of the press fit features.While no definitive root cause could be determined, it is likely that the condition was due to 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 during a routine inspection of the wrist fusion set on (b)(6) 2019, the handle with quick coupling was found to be defective.The end cap on the handle had disengaged and would not stay on.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: 8780595
• MDR Text Key: 150720489
• Report Number: 2939274-2019-59123
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: 06/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• 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