MAUDE Adverse Event Report: SYNTHES GMBH UNKNOWN BURRS & DRILLS; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number UNK-BURRS-&-DRILLS

Device Problems Material Fragmentation (1261); Separation Problem (4043)

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 the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.The catalog number, serial number and udi number were unknown.Pma/510(k) number was unknown.The device manufacture date is unknown.Concomitant device: drill burr attachment device.

Event Description

It was reported from (b)(6) that the cuter device was fractured while attached to the burr attachment device.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.H10 additional narrative: the actual device was returned for evaluation.The device was evaluated and it was determined that the reported condition was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the a part of a cutter device was stuck inside of the attachment.The part of the drill bit was visually inspected, but we were unable to fully determine the article number of the drill or the lot number.Most likely the cutting tool broke apart when a lateral load was applied.This can easily happen during usage of delicate cutting tools.The device also failed pretests for visual assessment.The assignable root cause was traced to component failure due to normal wear.

• Brand Name: UNKNOWN BURRS & DRILLS
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf FL 4436 ; SZ 4436
• MDR Report Key: 12259271
• MDR Text Key: 266601716
• Report Number: 1045834-2021-01326
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-BURRS-&-DRILLS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1