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

Catalog Number 50382110

Device Problems Break (1069); Difficult to Insert (1316); Detachment of Device or Device Component (2907)

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

Event Date 01/16/2015

Event Type  malfunction  

Event Description

3.0mm apex pins sheared off in patient's left tibia upon insertion.Rep reported that ¿tips sheard off immediately upon attempt of insertion.Put two different pins in and went ahead.¿.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event of the drill tips missing upon inspection could be confirmed.According to the investigation, the root cause was attributed to a r&d/design-related issue.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.R&d maintenance took over this case within the framework of a potential recurring situation identification board and reported the following: "the potential to improve the insertion behaviour shall be investigated" (please refer to the "prs_ref#5038_1_080-5_080_self-drilling half pin apex ø 3mm rev2" file in attachment).Tolerance field of the tip is to be reduced.(b)(4) has been opened and will address this failure mode.

Event Description

A 3.0mm apex pins sheared off in patient's left tibia upon insertion.Rep reported that "tips sheard off immediately upon attemp of insertion.Put two different pins in and went ahead.".

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer (Section G): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4477442
• MDR Text Key: 21239046
• Report Number: 0008031020-2015-00050
• Device Sequence Number: 1
• Product Code: JDW
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• 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: F35081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2014
• 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: 61 YR
• Patient Weight: 127