MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.2MM LINDEMANN DRILL BIT; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	1608002043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported via medwatch report 1901760000-2020-8045, that during a right hip hardware removal procedure, the bur broke.It was also reported that there were no adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
Event or Problem Description
It was reported via medwatch report (b)(4), that during a right hip hardware removal procedure, the bur broke.It was also reported that there were no adverse consequences as a result of this event.

• Brand Name: 2.2MM LINDEMANN DRILL BIT
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11146913
• Report Number: 0001811755-2021-00053
• Device Sequence Number: 3494604
• Product Code: GFF
• UDI-Device Identifier: 04546540030597
• UDI-Public: 04546540030597
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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 Expiration Date: 08/01/2022
• Device Model Number: 1608002043
• Device Catalogue Number: 1608002043
• Device Lot Number: 17223017
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR