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

Model Number 17-1325

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 306605602
• Report Number: 0008031020-2022-00542
• Device Sequence Number: 1
• Product Code: MPK
• UDI-Device Identifier: 00886385019840
• UDI-Public: 00886385019840
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female