MAUDE Adverse Event Report: SYNTHES GMBH BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.201

Device Problems Output below Specifications (3004); Physical Resistance/Sticking (4012)

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

Event Date 01/01/2020

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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device having low energy was not confirmed.Therefore, an assignable root cause was not determined.However, the reported condition of sticky trigger was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the trigger of the battery handpiece/modular device was sticky, and the part of the lower trigger had broken off.It was further determined that the housing was out of round and was deformed/bent, and the device was leaky, and it had a leak tightness test failure.It was determined that the device would not hold/secure the battery device, and it had a component damage.It was observed that the lid was unable to be fitted on.It was further determined that the device failed pretest for general condition, leakage test using bubble emission technique, check for sticky triggers, check roundness of housing, check falling out protection (steel ring), and check fitting of the lid.It was noted in the service order that during an unspecified surgical procedure, it was discovered that the device did not have enough energy to cut the bone.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.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 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY HANDPIECE/MODULAR FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: 11040906
• MDR Text Key: 222661061
• Report Number: 8030965-2020-09876
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: 07611819977815
• 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: 09/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2020
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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