MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 5MM, 150 X 40MM; PIN, FIXATION, THREADED

Model Number 5018-5-150

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/18/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.

Event Description

It was reported that when inserting the apex pin into the tibial diaphysis, the surgeon attached the apex pin to the handpiece and tried to insert it into the patient's bone, but when it was inserted about 10mm, it stopped progressing.The apex pin broke as soon as it was changed to the manual insertion.Since the tip of 10 mm remained on the bone, the broken tip was removed by scraping around it, the bone was shaved to remove the pin tip.The surgery was continued by inserting the apex pin in another position.

Event Description

It was reported that when inserting the apex pin into the tibial diaphysis, the surgeon attached the apex pin to the handpiece and tried to insert it into the patient's bone, but when it was inserted about 10mm, it stopped progressing.The apex pin broke as soon as it was changed to the manual insertion.Since the tip of 10 mm remained on the bone, the broken tip was removed by scraping around it, the bone was shaved to remove the pin tip.The surgery was continued by inserting the apex pin in another position.

Manufacturer Narrative

The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the tip of the received apex pin is completely broken / snapped off during insertion.The deformation of the screw thread clearly indicates that far too much mechanical force had been applied during insertion which finally led to the breakage of the tip.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿avoid surface damage of implants.Contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.If contouring is necessary, allowed by design or prescribed by stryker, the physician should avoid sharp bends, reverse bends or bending the device at a screw hole.Such action must be performed with stryker instruments and in accordance with the specified procedures (see operative technique).¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused due to application of high mechanical force during insertion.If any further information is provided, the complaint report will be updated.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 150 X 40MM
• 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: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12318870
• MDR Text Key: 266429969
• Report Number: 0008031020-2021-00363
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07613327091939
• UDI-Public: 07613327091939
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001886
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5018-5-150
• Device Catalogue Number: 50185150
• Device Lot Number: H22193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• 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 Age: 26 YR
• Patient Sex: Male