MAUDE Adverse Event Report: SYNTHES GMBH SAW BLADE 116/95*25*1.19; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.002.102

Device Problem Dull, Blunt (2407)

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

Event Date 09/27/2021

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.Concomitant med products and therapy dates: saw attachment device and quick coupling device, (b)(6) 2021.H6: device history review: a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported condition that the device did not work anymore was not confirmed.Therefore, an assignable root cause for the reported condition was not determined.However, during evaluation, it was determined that the device would not cut/dull.The assignable root cause resulting from failures identified during evaluation 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 saw blade device failed visual inspection and showed heavy signs of wear.It was determined that both sides of the device were severely grinded off and the outer teeth were damaged.It was observed that laterally the saw blade showed a ridge which indicated an impact occurred which most likely tightened the saw attachment clamping mechanism up to a degree so it was difficult to release the cutting tool by hand.It was noted in the service order that the device did not work anymore while in use with a saw attachment device and quick coupling device.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.

• 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: 12624020
• MDR Text Key: 276148516
• Report Number: 8030965-2021-08630
• Device Sequence Number: 1
• Product Code: GEY
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.002.102
• Device Lot Number: AO28461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1