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 Foreign Body In Patient (2687)

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

It was reported that surgeon was putting in an apex pin and the tip of the pin broke off in the patients' far cortesie and was un retrievable.Surgeon used a new pin and completed the case.

Manufacturer Narrative

The reported incident of the pin breakage could not be confirmed, since the device was not returned for evaluation.Based on the investigation, the root cause was attributed to a r&d/design related issue.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".(b)(4).Tolerance field of the tip is to be reduced.(b)(4) has been opened and will address this failure mode.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.No indications of material or manufacturing related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that surgeon was putting in an apex pin and the tip of the pin broke off in the patients' far cortesie and was un retrievable.Surgeon used a new pin and completed the case.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5091092
• MDR Text Key: 26533433
• Report Number: 0008031020-2015-00388
• 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: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• 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: F43474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: No
• 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: 77 YR
• Patient Weight: 99