MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX HA-COATED Ø 5MM, 180 X 40MM; PIN, FIXATION, THREADED

Catalog Number	50174180S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported on medwatch (b)(4): "during a surgical procedure removal external fixator of the right leg, removal of the frame the two anterior pins had fractured at the bone interface half of the pins was still remaining inside the femur, buried".Original intended procedure: removal of external fixator of the right leg.
Event or Problem Description
As reported on medwatch (b)(4): "during a surgical procedure removal external fixator of the right leg, removal of the frame the two anterior pins had fractured at the bone interface half of the pins was still remaining inside the femur, buried".Original intended procedure: removal of external fixator of the right leg.
Additional Manufacturer Narrative
The reported event that self-drilling half pin apex ha-coated ø 5mm, 180 x 40mm was alleged of 'breakage during surgery' could be confirmed, based on provided pictures.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Based on provided pictures, we can only confirm the event: tip of the pin is broken.Further inspection is not possible without the returned device.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SELF-DRILLING HALF PIN APEX HA-COATED Ø 5MM, 180 X 40MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8139814
• Report Number: 0008031020-2018-01034
• Device Sequence Number: 950221
• Product Code: JDW
• UDI-Device Identifier: 07613154493333
• UDI-Public: 07613154493333
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 50174180S
• Device Lot Number: L31110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 83