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

Model Number 311.44

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown date, it was identified in sterile processing department that the hexagonal screwdriver attachment was stuck on the t-handle with quick coupling and will not come off.There is no patient involvement.Concomitant device reported: large hexagonal screwdriver (part # 314.27, lot # unknown, quantity 1).This report is for one (1) t-handle with quick coupling.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part 311.44, lot 4909173: release to warehouse date: december 28, 2004.Supplier: brandywine.No non-conformance reports (ncr¿s) 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 completed: upon visual inspection, it was noticed that the t-handle was stuck to the hexagonal screwdriver.Thus, the complaint is being confirmed.Functional testing of the received device was performed by pulling apart, but the devices were unable to be separated.Dimensional inspection was unable to be performed on the device due the received stuck condition of the measurable feature.The relevant drawing was reviewed; no design issues or discrepancies were found during this investigation.The complaint condition is confirmed.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.Physical manufacturer.

• Brand Name: T-HANDLE WITH QUICK COUPLING
• Type of Device: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10971260
• MDR Text Key: 220477139
• Report Number: 2939274-2020-05503
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187413
• UDI-Public: (01)10886982187413
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.44
• Device Catalogue Number: 311.44
• Device Lot Number: 4909173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LARGE HEXAGONAL SCREWDRIVER; LARGE HEXAGONAL SCREWDRIVER