MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM; PIN, FIXATION, THREADED

Catalog Number 50382110

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.More detailed information about the complaint event must be available in order to determine the root cause of the event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : broken pin left inside patient tibia bone.

Event Description

It was reported by the sales rep that one of the navigation pin was broken and left inside patient tibia bone when surgery finishing and surgeon was drilling the pin out.Surgeon decided to leave it inside the patient bone.Hospital raised serious incidence report because it was considered as "sharp".Based on the information provided by the surgeon/hospital, the broken pin was not removed from the patient's bone.Patient was discharged to-date.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM
• Type of Device: PIN, FIXATION, THREADED
• 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: 18946712
• MDR Text Key: 338185266
• Report Number: 0008031020-2024-00126
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07613327091748
• UDI-Public: 07613327091748
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K861766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50382110
• Device Lot Number: AD3321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other