MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-HANDLE HXC-SMALL; SCREWDRIVERS

Model Number 03.507.000

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) 2020, the two (2) trays; matrix mandible and matrix midface tray were inspected because the trays had fallen from a shelf in the sterile processing department (spd).Several parts were noted to be damaged in the tray.One (1) bone reduction forcep had a broken fine tip, one (1) screwdriver handle was broken end cap is missing, one (1) matrixmandible drill guide broken tip damage on which the drill bit would not easily sliding through, and one (1) t-handle was broken slide is very loose.There was no patient involvement.This is report 4 of 4 for (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.Additional information: h3, h4, h6: part number: 03.507.000.Lot number: t107269.Manufacturing site: tuttlingen.Release to warehouse date: october 1, 2014.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.Visual inspection: the t-handle hxc-small (p/n: 03.507.000, lot number: t107269) was received at us customer quality (cq).Upon visual inspection, the sleeve is loose.No external damage was observed.Functional test: a functional assessment was performed with the complaint device.The complaint device sleeve component is loose and jiggles when moved.The complaint condition can be replicated.Dimensional inspection: no dimensional inspection was performed due to inaccessibility of internal components.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the sleeve component is loose.However, no external damage was observed.No definitive root cause could be determined based on the provided information.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.

• Brand Name: T-HANDLE HXC-SMALL
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10020851
• MDR Text Key: 196119833
• Report Number: 2939274-2020-02220
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10887587014142
• UDI-Public: (01)10887587014142
• 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
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.507.000
• Device Catalogue Number: 03.507.000
• Device Lot Number: T107269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1