MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL PHALANGEAL BROACH, SIZE 1 SR PIP; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Model Number	17-1325
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the size 1 proximal broach tip broke off in the patients phalange while the surgeon was trying to remove the broach.Sequential broaching (up to size 2) was completed.The tip remained in the patient as removal would have been significantly more invasive." there was a 5 minute delay to the procedure.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and is indeed broken.The device inspection could confirm the catalog and lot numbers reported were correct, and that tip of the broach is indeed broken.The device shows various scratches, which could be attributed to multiple years of use and reprocessing.The tip of the device shows a brittle fracture, showing that the instrument broke in a sudden manner, following the application of an important force.Based on investigation, the root cause was attributed to a user related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the size 1 proximal broach tip broke off in the patients phalange while the surgeon was trying to remove the broach.Sequential broaching (up to size 2) was completed.The tip remained in the patient as removal would have been significantly more invasive." there was a 5 minute delay to the procedure.

• Brand Name: PROXIMAL PHALANGEAL BROACH, SIZE 1 SR PIP
• Common Device Name: SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15593974
• Report Number: 0008031020-2022-00542
• Device Sequence Number: 13987316
• Product Code: MPK
• UDI-Device Identifier: 00886385019840
• UDI-Public: 00886385019840
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/20/2023

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 Model Number: 17-1325
• Device Catalogue Number: 171325
• Device Lot Number: 038801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female