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

Model Number 532.110

Device Problems Noise, Audible (3273); Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.The small battery drive device was evaluated and the reported condition that the device had internal rattling, and the speed of the device was inconsistent was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had insufficient/low power, a worn motor, and worn bearings.It was further determined that the device failed pretest for check the power with the test bench.The assignable root cause of these conditions was determined to be traced to component failure due to normal wear.Udi ¿ (b)(4).

Event Description

It was reported that during pre-surgery testing for an open reduction internal fixation (orif) surgical procedure for the right elbow, it was observed that the small battery drive device had internal rattling while in use, and the speed of the device was inconsistent.It was reported that there was no delay in the procedure due to the event as an unspecified spare device was available for use.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE II
• 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: 11769160
• MDR Text Key: 248792581
• Report Number: 8030965-2021-03324
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10886982241191
• UDI-Public: 10886982241191
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532.110
• Device Catalogue Number: 532.110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• 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