MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM WIRE PASS DRILL MEDIUM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5300010063
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device was discarded.
Event or Problem Description
It was reported that during an osteoplasty procedure, the bur broke and the fragment logged in the patient¿s soft tissue.It was further reported that the surgeon retrieved the broken fragment which resulted in a thirty minute delay to the procedure.
Event or Problem Description
It was reported that during an osteoplasty procedure, the bur broke and the fragment logged in the patient¿s soft tissue.It was further reported that the surgeon retrieved the broken fragment which resulted in a thirty minute delay to the procedure.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: 1.5MM WIRE PASS DRILL MEDIUM
• 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: 11581378
• Report Number: 3015967359-2021-00291
• Device Sequence Number: 4183371
• Product Code: GFF
• UDI-Device Identifier: 07613153000037
• UDI-Public: 07613153000037
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: 5300010063
• Device Catalogue Number: 5300010063
• Device Lot Number: 1924007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention