MAUDE Adverse Event Report: SYNTHES GMBH SAW BLADE 116/95*19*1.19; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 05.002.002

Device Problem Dull, Blunt (2407)

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.The actual device was returned for evaluation.Quality engineering evaluated the saw blade device and it was determined that the device showed heavy signs of wear.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.A review of the device history was performed and no non-conformances were detected related to the reported condition.Udi (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the saw blade device showed heavy signs of wear.It was noted that both sides of the device were severely grinded off and all teeth were damaged.Laterally the saw blade showed a ridge which indicates 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 further determined that the device failed pretest for visual assessment.It was noted in the service order that post procedure it was observed that the device ¿spoiled¿.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 not reported, however, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 12676897
• MDR Text Key: 278158099
• Report Number: 8030965-2021-08877
• Device Sequence Number: 1
• Product Code: GFA
• 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: 09/29/2021

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: 05.002.002
• Device Lot Number: AO28397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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