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 Problems Dull, Blunt (2407); Separation Problem (4043)

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

Event Date 01/01/2022

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 device and it was determined that the device showed heavy signs of wear.It was further determined that it was difficult to release the cutting tool by hand.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure from wear.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.Udi: (b)(4).

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the saw blade device showed heavy signs of wear.It was observed that both sides of the device were severely grinded off and all teeth were damaged.It was further determined 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 saw blade device was stuck and unable to be removed from the attachment device.It was further noted that the hospital tried to remove it but because of the jamming it did not work.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 unknown.However, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should 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: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 14367371
• MDR Text Key: 291508820
• Report Number: 8030965-2022-02993
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• 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: AO23284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• 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