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

Catalog Number 532.001

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

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.Service review: a review of the service history record indicates that the device has been serviced within the last year for a service condition that is not relevant to the current reported condition.Device evaluation: the actual device was returned for evaluation.During repair, quality engineering performed evaluation and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).

Event Description

It was reported by (b)(6) that during in-house engineering evaluation, it was determined that the small battery drive device was not running in oscillating mode.The device was disassembled, and the electric motor and electronic control unit (ecu) were measured separately to identify where the failure persisted.After the measurements, it was concluded that the malfunction was related to the ecu.It was determined that the control unit did not pass testing in the oscillating mode.It was determined that the device did not show any changes, whether the mode switch was in oscillation or on position.When two triggers were pressed together, it was determined that the device changed only in the rotating direction.It was further determined that the anodized surfaces of the device were used up.It was observed that the device had corrosion/rusting/pitting, and it ran in an unexpected direction/mode and would not oscillate.It was further determined that the device failed pretest for general condition, check the off/oscillation/on switch mode function, check the oscillation angle, check compatibility between colibri i and colibri ii and check the function with electric pen drive console.It was noted in the service order that the device was making strange sounds while running.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 10416280
• MDR Text Key: 204223888
• Report Number: 8030965-2020-05902
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 08/07/2020
• Date Device Manufactured: 02/16/2012
• 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