MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MULTI PURPOSE OSTEOTOME, SLIGHT CURVED, 6MM WIDE; INSTRUMENT

Model Number	01-04070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure the tip of the device broke off into the bone of the patient.The fragment was recovered intraoperatively which resulted in a surgery delay.
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Additional Manufacturer Narrative
Updated information: d9, h3, h6 device evaluation: follow-up report submitted to document the device evaluation.The initially reported event that the osteotome broke could be confirmed, because of the visual inspection.The tip is broken off and there are cracks visible.The fracture surface shown an intercrystallite fracture due to mechanical bending overloads.Based on the investigation, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issue.
Event or Problem Description
It was reported that during the procedure the tip of the device broke off into the bone of the patient.The fragment was recovered intraoperatively which resulted in a surgery delay.

• Brand Name: MULTI PURPOSE OSTEOTOME, SLIGHT CURVED, 6MM WIDE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16870676
• Report Number: 0008010177-2023-00025
• Device Sequence Number: 5460562
• Product Code: LXH
• UDI-Device Identifier: 04546540134998
• UDI-Public: 04546540134998
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: 01-04070
• Device Catalogue Number: 01-04070
• Device Lot Number: CF45/14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown