MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 3MM, 80 X 15MM; PIN, FIXATION, THREADED

Catalog Number	50382080S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During surgery, the tip of the pin broke when the surgeon was inserting it to the patient.The tip of the pin is remained to the patient.
Additional Manufacturer Narrative
The reported event that the self-drilling half pin apex ø 3mm, 80 x 15mm broke during surgery could be confirmed.The x-ray provided confirmed that the tip of the pin remained in the patient humerus.Additionally, the device inspection revealed that the pin is bend and broken.The breakage surface is consistent with a breakage due to torsional overload of the device.Based on the investigation, the root cause was determined to be user related.The failure was caused by the selection of the wrong pin size.It is recommended by the operative technique to use a 4 or 5 mm pin in the humerus.In the present event a 3 mm pin was used, which is a clear contradiction of the instructions given.As the humerus is a stronger bone than the forearm, it will create a higher resistance to pin insertion and so, to prevent events like the present one, a higher diameter pin must be selected.Note, as stated in the operative technique (apex-st-1 en apex pins op tech): ¿as a guideline one might use the following diameters: ¿ forearm: 3mm (distal) and 4mm (proximal) apex pins ¿ humerus: 5mm apex pins, 4mm in distal fragments ¿ femur and pelvis: 5mm apex pins throughout the entire bone ¿ tibia: 5mm apex pins ¿ ankle: 5mm or 5mm transverse apex pins¿ [original statements].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 or manufacturing related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
During surgery, the tip of the pin broke when the surgeon was inserting it to the patient.The tip of the pin is remained to the patient.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 80 X 15MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6185331
• Report Number: 0008031020-2016-00605
• Device Sequence Number: 16498488
• Product Code: JDW
• UDI-Device Identifier: 04546540435392
• UDI-Public: (01)04546540435392(17)210228(10)V06393
• Combination Product (Y/N): N
• PMA/510(K) Number: K001886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 50382080S
• Device Lot Number: V06393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/17/2017
• 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: Other
• Patient Age: 44 YR