MAUDE Adverse Event Report: SYNTHES GMBH SAW BLADE 106/85*25*1.47; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 05.002.401

Device Problems Fracture (1260); Separation Problem (4043)

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

Event Date 10/26/2021

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 not returned for evaluation, however, a photo of the device was returned.Quality engineering evaluated the photo and the reported condition that the saw blade device could not be removed from the attachment device could not be confirmed.Therefore, an assignable root cause was not determined.However, during evaluation the following failure could be identified: the outer teeth of the saw blade were found to be deformed.A piece of the surface on the saw blade broke off.It was determined that the fracture was caused due to the oscillating saw blade meeting the metal sawing guide during operation.It was determined that pressure or contact with the sawing guide was applied and finally led to breakage of a piece of the saw blade.The assignable root cause of this condition was determined to be traced to improper handling, by the user, which is user error.Udi ¿ (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the outer teeth of the saw blade device were found to be deformed.A piece of the surface on the saw blade broke off.It was noted in the service order that the saw blade device could not be removed from the attachment 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 become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: a review of the device history was performed and no non-conformances were detected related to the reported condition.

• 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: 12869166
• MDR Text Key: 281207008
• Report Number: 8030965-2021-09755
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.002.401
• Device Lot Number: AO24124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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