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); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Apex pin tip broke off in near cortices of patients left tibia.Surgeon extracted the tip with a quick out.He used another apex pin to complete the surgery.

Manufacturer Narrative

Evaluation summary: the reported incident that self-drilling half pin apex ø 3mm, 110 x 25mm was alleged of issue s-11 (breakage during surgery) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inappropriate size selection.This was a tibia surgery and the surgeon used a 3mm diameter pin.Please note that the operative technique reads: ¿'among others, the pin diameter influences axial frame rigidity.This is because the stiffness of the pin is a function of the forth power of the diameter.As a guideline one might use the following diameters: [¿] ¿ tibia: 5mm apex pins¿ [original statement] however, r&d maintenance took over this failure mode within the framework of a potential recurring situation identification board and reported the following: ''the potential to improve the insertion behaviour shall be investigated.Tolerance field of the tip is to be reduced.¿ nc has been opened and will address this failure mode.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.Product was lost.

Event Description

Apex pin tip broke off in near cortices of patients left tibia.Surgeon extracted the tip with a quick out.He used another apex pin to complete the surgery.Primary surgery.

• 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 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5047133
• MDR Text Key: 25350534
• Report Number: 0008031020-2015-00367
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07613327091748
• UDI-Public: 07613327091748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K861766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50382110
• Device Lot Number: F31155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• 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
• Patient Age: 55 YR
• Patient Weight: 88