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

Catalog Number 014395

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported small spirals of metal shavings came off and contained around the entry point tissue.

Manufacturer Narrative

Examination is not possible, as the device has not been returned, however a photographs were provided.The photo shows a bent passing pin.The pin is scored along its length and shows major metal debridement at the bend location.It appears that during placement of the passing pin the pin became bent causing it to come in contact with the drill guide resulting in the observed shedding.Further investigation is not warranted at this time.

Manufacturer Narrative

The product and photo were reviewed and it was confirmed that the passing pin is bent.The passing pin is scored along its length and shows major metal debridement at the bend location.It appears that during placement of the passing pin the pin became bent causing it to come in contact with the drill guide resulting in the observed shedding.Drilling with a bent passing pin would require the use of excessive force.Excessive forces applied to the instrument can result in failure¿.Further investigation is not warranted at this time.

• Brand Name: PASSING PIN,2.4MM
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6236319
• MDR Text Key: 64712570
• Report Number: 3003604053-2017-00005
• Device Sequence Number: 1
• Product Code: HWQ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 014395
• Device Lot Number: 50609786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR