MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (9.0 X 0.38 X 31.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2296003125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that after an osteotomy procedure, the surgeon noticed that a part of the connector between the blade and the handpiece was broken and stayed in patient's body.It was also reported that the patient experienced pain and an additional surgery was performed to remove the blade fragment.It was also reported that there were no delays as a result of this event and the procedure was completed successfully.
Event or Problem Description
It was reported that after an osteotomy procedure, the surgeon noticed that a part of the connector between the blade and the handpiece was broken and stayed in patient's body.It was also reported that the patient experienced pain and an additional surgery was performed to remove the blade fragment.It was also reported that there were no delays as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: PRECISION THIN (9.0 X 0.38 X 31.0MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10502255
• Report Number: 0001811755-2020-02330
• Device Sequence Number: 2902825
• Product Code: GFA
• UDI-Device Identifier: 04546540046529
• UDI-Public: 04546540046529
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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 Model Number: 2296003125
• Device Catalogue Number: 2296003125
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/01/2020
• 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