MAUDE Adverse Event Report: SYNTHES GMBH BURR ATTACHMENT-LONG-ANGD FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	05.001.050
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional 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 intial reporter's complete name and phone number were not provided.The actual device was returned for evaluation.The device was evaluated and it was determined that the reported condition that the device was overheating not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device had worn bearings, moving parts did not move smoothly and failed pretest for check for free movement.The assignable root cause resulting from failures identified during evaluation was determined to be due to component failure from wear.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during post-surgery, it was discovered that the burr attachment device overheated.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 not reported.However, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BURR ATTACHMENT-LONG-ANGD FOR PEN DRIVE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12293965
• Report Number: 8030965-2021-06107
• Device Sequence Number: 3165215
• Product Code: HWE
• UDI-Device Identifier: 07611819167964
• UDI-Public: 07611819167964
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.050
• Device Lot Number: L625041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1