MAUDE Adverse Event Report: SYNTHES GMBH UNKNOWN BURRS & DRILLS; BLADE, SAW, GENERAL & 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 11/12/2021

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.Additional narrative: the reporter's phone number was not provided.Concomitant med products and therapy dates: drill/burr attachment device, (b)(6) 2021.Udi: the brand name, catalog number, lot number and device manufacture date were unknown, therefore the udi is unknown.The manufacturing location is unknown.Pma/510(k) number was unknown.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that the drill/burr attachment device was returned with a fragment of a burr device jammed inside it.It was not reported if the device was used in surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available for use.There was no human patient involvement as the facility is a veterinary medical clinic, and therefore, the device is most likely used for veterinary purposes only.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 report will be submitted accordingly.

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.Additional narrative: device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device.A functional assessed was performed and it was determined that the device failed visual inspection.During the assessment of the attachment device, it was found that there was a stuck fragment from a drill bit device inside of the tool coupling.It was determined that the fragment was too small to identify the article number or lot number of the fragment.The fragment was only found during the assessment of the attachment.It was determined that it was not possible to remove the fragment from the tool coupling.It was determined that the most probable cause for the found defect was due to improper handling by the user.It was determined that the drill bit broke inside of the coupling.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.

• Brand Name: UNKNOWN BURRS & DRILLS
• 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: 12982831
• MDR Text Key: 286948023
• Report Number: 8030965-2021-09806
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 11/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• 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: 11/29/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1