MAUDE Adverse Event Report: SYNTHES GMBH COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 532.101

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 01/01/2021

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.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the small battery drive device had a sticky trigger and would not run-motor damaged.It was further determined that the device failed pretest for check for sticky triggers, check function of device and check power with power test bench.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COLIBRI II HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12703064
• MDR Text Key: 278567139
• Report Number: 8030965-2021-09016
• Device Sequence Number: 1
• Product Code: HWE
• 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,foreig
• Type of Report: Initial
• Report Date: 10/18/2021

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: 532.101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• 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