MAUDE Adverse Event Report: SYNTHES GMBH HANDLE WITH MINI QUICK COUPLING; BONE TAP

Catalog Number 311.01

Device Problem Material Integrity Problem (2978)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that on an unknown date, instrument was reported for reason not specified.This was a pre op case, so there was no patient involvement.During the service and repair evaluation it was identified that the instrument could not hold the bit.This report involves one (1) handle with mini quick coupling.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.H10 additional narrative: e3: reporter is a j&j employee.H3, h4, h6: part # 311.01 synthes lot # 6222876 supplier lot # n/a release to warehouse date: 15 sep 2009 manufactured by: synthes brandywine no 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.Service and repair evaluation: the customer reported that the device 311.01, handle with mini quick coupling was reported for unknown reason.The repair technician reported that unable to hold bit.Chuck broken/loose is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The evaluation was confirmed.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: HANDLE WITH MINI QUICK COUPLING
• Type of Device: BONE TAP
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17745203
• MDR Text Key: 323397748
• Report Number: 8030965-2023-11558
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187192
• UDI-Public: 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 311.01
• Device Lot Number: 6222876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2009
• 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