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

Catalog Number 311.43

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is synthes sales consultant.A device history record (dhr) review was conducted: part # 311.43, synthes lot # h391110, supplier lot # h391110, release to warehouse date: 03 nov 2017, supplier: (b)(6).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.Visual inspection: upon visual inspection, there was no defect was found.Functional test: the coupling sleeve is able to move forward and back appropriately with no mating device inserted.Replication of complaint condition was not possible as the mating device was not returned.Complaint can't be confirmed drawing/document specification review: relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) and no design issues were noted.Dimensional inspection: dimensional analysis performed on the internal shaft measured the diameter and it falls within the specification per relevant drawing.Conclusion: the complaint can't be confirmed.We cannot determine a root cause for why the customer experienced the reported problem.During the investigation no design/manufacturing issues were identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 the routine checks in sterile processing department, it was noticed that a handle with quick coupling was not holding anything very well that was put in the handle.There was no patient involvement.  this report is for one (1) handle with quick coupling, small.This is report 1 of 1 for complaint (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: 8562633
• MDR Text Key: 144129157
• Report Number: 2939274-2019-57728
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.43
• Device Lot Number: H391110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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