MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.3MM INLINE DRILL GUIDE ¿ FISHMOUTH TIP; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72201105

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2013

Event Type  malfunction  

Manufacturer Narrative

Subject device is a reusable item.However, it cannot be confirmed whether it was reprocessed.Subject device was returned for evaluation.Visual inspection confirmed the failure mode of ¿dimensional¿.The overall length dimension was found to be beyond the specification limit.Further assessment found the end of the device to have damage consistent with an impact with a hard object.An attempt was made to pull the shaft from the handle by hand.However, the shaft was firmly lodged within the handle and could not be removed.Review of the device history records was performed which confirmed no discrepancies.A complaint history review for the catalog number has not identified additional complaints filed for the manufactured lot.Per the evaluation, no root cause could be determined.At this time, no further investigation will be implemented.(b)(4).

Event Description

During a superior labrum anterior and posterior (slap) procedure utilizing the 2.3mm inline drill guide "fish mouth tip, it was noted that the shaft was elongated.It was reported that the anchor sat proud due to the guide not allowing drilling deep enough to allow the anchor to be implanted.It was reported that the only option was to mallet the anchor into position.It was reported that nothing was left open and the anchor was used for fixation.It was reported that a backup device was used and there were no further issues during the surgery.(b)(4).

• Brand Name: 2.3MM INLINE DRILL GUIDE ¿ FISHMOUTH TIP
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4976370
• MDR Text Key: 23810319
• Report Number: 1219602-2015-00739
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201105
• Device Lot Number: 50323062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1