MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ACF TRIAL SPACER HANDLE; FORCEPS

Model Number 396.989

Device Problem Compatibility Problem (2960)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is a synthes employee.The device has been 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 during evaluation at loaner department on (b)(6) 2020, the inner shaft of the acf trial spacer handle was noticed to have stuck.There were no patient and surgical involvement.This report involves one (1) acf trial spacer handle.This is report 1 of 1 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, h6: part: 396.989.Lot: 3711328.Manufacturing site: hägendorf.Release to warehouse date: april 11, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: acf trial spacer handle was received at us customer quality (cq).Upon visual inspection at cq, it is observed that the device was received intact.The surface of the device shows cosmetic wear which would not contribute to the complaint condition.Functional test: functional testing of the received device was performed at cq.The circular knob near handle was rotated to rotate the threaded shaft of the device.The knob was facing some resistance and hard to rotate.Thus, the reported complaint of stuck condition is being confirmed.Can the complaint be replicated with the returned devices? yes.Dimensional inspection: dimensional inspection of the relevant features cannot be performed as the internal components of the device are inaccessible.Document/ specification review: the following drawing(s) was reviewed; raendelhuelse kpl.Implant holder 4.5.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: visual inspection, functional test, and document specification review of the received device was performed at cq.The complaint is being confirmed as the knob was facing some resistance and hard to rotate.A definitive root cause could not be determined for the complaint condition.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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: ACF TRIAL SPACER HANDLE
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10047770
• MDR Text Key: 190658309
• Report Number: 2939274-2020-02311
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10705034778198
• UDI-Public: (01)10705034778198
• 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: 04/29/2020

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: 396.989
• Device Catalogue Number: 396.989
• Device Lot Number: 3711328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1