MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE PASSING PIN 13.50 X 2.4MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72201594
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during acl surgery when the surgeon made the bone hole, the flexible passing pin was found to be broken; the procedure was successfully completed with minimal delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
A 72201594 flexible passing pin used in treatment, was not returned.This product is sold as a 5 pack.These nitinol pins have ability to flex but not be bent.Physical evaluation was limited with no item returned.Factors that may affect device performance include: device ability, implant location and tissue condition.Review of instruction for use documentation contains precautionary statements and recommendations for proper use of product.Other influences that may compromise performance or integrity include: 1 getting entangled up with other instruments or devices.2 condition the driver¿s bit or chuck.3 stripping or over-torque use.4 debris such as bone chips caught in the bit or chuck.5 unexpected bone density/condition.Per instruction for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.These wire may snap when subjected to excess stress.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
A flexible passing pin used in treatment, returned for evaluation.From the information provides, passing pin broke.An exact root cause cannot be determined with confidence, however; factors that may affect device performance include: device ability, implant location and tissue condition.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Risk management files contain the reported failure.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: FLEXIBLE PASSING PIN 13.50 X 2.4MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10422672
• Report Number: 1219602-2020-01264
• Device Sequence Number: 3974486
• Product Code: GEI
• UDI-Device Identifier: 03596010601452
• UDI-Public: 03596010601452
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162074
• 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,Followup
• Report Date (Section B): 10/06/2020

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: 03/26/2024
• Device Model Number: 72201594
• Device Catalogue Number: 72201594
• Device Lot Number: 50795971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020; 10/05/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/21/2020; 10/06/2020
• 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
• Patient Age: 40 YR