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

Model Number	5018-5-150
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0008031020-2021-00363
• Device Sequence Number: 4541745
• Product Code: JDW
• UDI-Device Identifier: 07613327091939
• UDI-Public: 07613327091939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001886
• 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): 11/09/2021

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 26 YR
• Patient Sex: Male