MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PASSING PIN 2.4MM; PASSER

Model Number	014395
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an acl surgery, when the surgeon was drilling through the femur, the tip of the passing pin broke off.No significant delay was reported (<5 minutes).Smith and nephew back up device was used to complete the surgery.Broken pieces were removed using tweezers.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: one 014395 passing pin 2.4mm used during treatment, was not retuned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.The information provided states ¿during an acl surgery, when the surgeon was drilling through the tibia the tip of the 2.4mm broke off, it was also reported that when the femur was being drilled the tip broke off again¿.An exact root cause cannot be determined with confidence.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was performed, no other complaints of this failure was found.

• Brand Name: PASSING PIN 2.4MM
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10272108
• Report Number: 1219602-2020-01028
• Device Sequence Number: 16967564
• Product Code: HWQ
• UDI-Device Identifier: 03596010374684
• UDI-Public: 03596010374684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K920621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: 014395
• Device Catalogue Number: 014395
• Device Lot Number: 2031264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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