MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PIGALILEO NAV PAC SPEED-PINS 3.2,110(6X); PIN, FIXATION, SMOOTH

Model Number	75009340
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a piece of an unknown device was found intraoperatively.Found under x-rays and a procedure was required immediately to retrieve it.The piece is approximately 10mm x 4mm.A delay longer than 30 minutes was reported.No device backup required.
Additional Manufacturer Narrative
It was reported that the tip of a speed pin (75009340) broke off during surgery.The surgeon decided to perform a second surgery to remove the pin, which was performed without further complications.The tip of the pin could be removed, however it was not sent back as the cleaning team threw it away.Therefore, the speed pins, used in treatment, were no returned for investigation.The surgery was performed using a loaner set.The loaner inspection team checked all pins after surgery, none of the pins had a pin missing.The surgeon was sure that it was one of the speed pin tips, however we could not confirm this issue.The production documentation could not be reviewed, as it is not clear which pin broke.There were two more complaints reported in the past, in both cases the pins were not sent back for evaluation.A risk management review confirmed that the risk in scope is covered.A medical assessment could confirm, based on the provided x-rays, that an object remained in the patient.No part number was readable.As the pin was not sent back and no defective pin was found in the set, we cannot confirm the failure mode.Also the root cause cannot be determined after investigation.Further actions are no deemed necessary as no defective pin was found during the loaner inspection.Smith and nephew will monitor this device for further similar issues.

• Brand Name: PIGALILEO NAV PAC SPEED-PINS 3.2,110(6X)
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9387514
• Report Number: 9613369-2019-00096
• Device Sequence Number: 2669886
• Product Code: HTY
• UDI-Device Identifier: 07611996100549
• UDI-Public: 07611996100549
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: No Information
• Device Model Number: 75009340
• Device Catalogue Number: 75009340
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 03/09/2020
• 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