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

Model Number 014395

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/22/2020

Event Type  Injury  

Event 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.

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
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10272108
• MDR Text Key: 198753773
• Report Number: 1219602-2020-01028
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010374684
• UDI-Public: 03596010374684
• Combination Product (y/n): N
• PMA/PMN Number: K920621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention