MAUDE Adverse Event Report: SYNTHES GMBH SMALL BATTERY DRIVE CASING F/ 14.4 VOLT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.132

Device Problem Premature Separation (4045)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.An evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was traced to component failure due to normal wear.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during service and repair/pre-testing, it was observed that the small battery drive casing device disengaged unexpectedly, the contact was damaged and the device would not secure/hold the battery device.It was further determined that the device failed pretest for check the contacts and attached/locking check.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE CASING F/ 14.4 VOLT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 11475219
• MDR Text Key: 244947799
• Report Number: 8030965-2021-01459
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819418301
• UDI-Public: 07611819418301
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• 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