MAUDE Adverse Event Report: SYNTHES GMBH SAW BLADE 111/90*12.5*1.27; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 05.002.203

Device Problem Dull, Blunt (2407)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device saw blade was heavily worn and showed scratches on surfaces on both sides and a long lateral ridge.It was was also found that the device lateral ridge is a sign of impact which most likely occurred while cutting inside a cutting block.With the lateral impact, the saw blade clamping mechanism can be tightened up to a degree, so it becomes difficult to open it manually.Debris was also found between the cutting teeth.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear and improper re-processing.Concomitant medical devices and therapy dates, broach adaptor device, (b)(6) 2021.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the saw blade device was heavily worn and showed scratched surfaces on both sides and a long lateral ridge.It was noted in the service order that the device did not work properly anymore and was being used with (2) saw attachment devices.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, an additional report will be submitted accordingly.

• Type of Device: BLADE, SAW, GENERAL AND 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: 12374441
• MDR Text Key: 268463193
• Report Number: 8030965-2021-07234
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.002.203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1