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

Catalog Number 532.101

Device Problems Device Slipped (1584); Physical Resistance/Sticking (4012)

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

Event Date 08/18/2021

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.The actual device was returned for evaluation.Quality engineering evaluated the small battery drive device, and it was determined that the on/off trigger of the device had become loose, and when it was pressed it was turning and was not aligned with the upper trigger.Therefore, the reported condition was confirmed.However, the assignable root cause was not determined.It was further determined that the reported condition of the detected residues inside the trigger assembly could be linked to improper reprocessing.The assignable root cause of this condition was determined to be traced to environmental conditions.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.Udi ¿ (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the on/off trigger of the small battery drive device had become loose.It was noted that the trigger was in place and caused the device to run when it was pressed but it was turning and not aligned with upper trigger.The trigger was disassembled, and residues could be detected inside the assembly.A clear root cause as to why the trigger flange became loose could not be determined.It was determined that either the flange was not properly tightened during last repair, or it was manipulated, for instance, during reprocessing at the customer site after repair.No significant traces could be verified on the device.It was further determined that the device failed pretest for visual assessment and general condition.It was noted in the service order that the trigger for speed regulation is not fixed and turns.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 become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COLIBRI II HANDPIECE
• 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: 12589866
• MDR Text Key: 275179526
• Report Number: 8030965-2021-08461
• 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: 08/19/2021

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: 09/07/2021
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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