MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM; PIN, FIXATION, THREADED

Catalog Number 50185120

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported via the fda maude report mw5041717, volun 01-apr-2015: during surgery of tibia, a screw tip of external fixator pin, broke off inside the patient's tibia.Surgeons decided to leave the tip in place to avoid damage to the patient's tibia.

Manufacturer Narrative

The reported incident that self-drilling half pin apex ø 5mm, 120 x 35mm 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.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 behavior shall be investigated.Tolerance field of the tip is to be reduced.Nc#922344 has been opened and will address this failure mode.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not returned.

Event Description

It was reported via the fda maude report mw5041717, volun 01-apr-2015: during surgery of tibia, a screw tip of external fixator pin, broke off inside the patients tibia.Surgeons decided to leave the tip in place to avoid damage to the patient's tibia.Additional information as per rep 8/25/2015 "op note doesn't say.Spent a few minutes trying to remove it then left it in because it was imbedded in bone.".

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM
• 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: 4922991
• MDR Text Key: 22449512
• Report Number: 0008031020-2015-00305
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 50185120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other