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

Model Number 311.01

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted: part # 311.01, synthes lot # 6614074, supplier lot # na, release to warehouse date: 03/10/2011, manufactured by synthes (b)(4).No non-conformance reports (ncrs) 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.A product investigation was conducted.Service & repair evaluation: the customer reported that it was difficult to get coupling to open, insert and hold driver shaft.The repair technician reported the device required further testing at the vendor due to failed operation.Damaged coupler is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item was scrapped and will be forwarded to customer quality.The evaluation was confirmed.Visual inspection: upon visual inspection, the distal coupling mechanism was stuck in the retracted position and it would not fully open.The balance of the device shows surface wear consistent with use and which would not impact the functionality.Functional test: functional testing could not be performed with the mating blades/shafts as they were not returned for evaluation.However, functional testing of the coupling mechanism showed that the mechanism could not be released from the retracted position.In the advanced state the mechanism locks onto the mating screwdriver and in the retracted state the mechanism releases the mating screwdriver.Thus, in this retracted position, the device would not be expected to retain the mating screwdriver.Dimensional inspection: inner distal was measured and found to be conforming per relevant drawings.Document review: the relevant documents were reviewed as part of this investigation: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: the complaint condition of is confirmed.No new issues were identified on the remaining portions of the device.Although a root cause could not be definitely determined given the unknown circumstances, it is probable that an unintended force during usage/ handling such as dropping off the floor excessive loading and/or rough handling over 7+ years in the field contributed to the complaint condition.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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 routine set maintenance, it was found out that the handle with mini quick coupling had difficulty getting coupling to open, insert and hold driver shaft.There was no patient involvement.  concomitant devices reported: unknown  screwdriver shaft (part# unknown, lot# unknown, quantity# 1).This report is for one (1) handle with mini quick coupling.This is report 1 of 1 for complaint (b)(4).

• Brand Name: HANDLE WITH MINI QUICK COUPLING
• 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: 8495391
• MDR Text Key: 142507951
• Report Number: 2939274-2019-57398
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187192
• UDI-Public: (01)10886982187192
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.01
• Device Catalogue Number: 311.01
• Device Lot Number: 6614074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2011
• 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