MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL,FLEX,CRVD, FOR 2.3 SA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203160

Device Problem Metal Shedding Debris (1804)

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

Event Date 03/17/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Visual assessment of the drill shows the non-flexible portion of the drill shaft is bent.There is surface scoring along its length, no evidence of material missing.The flexible tip is bent consistent with use.Examination of the tip using a stereo microscope showed surface scoring but no evidence of any material missing.The bent condition of the device is consistent with not maintaining axial alignment during the drilling process.Per the device ifu under warnings ¿maintaining guide alignment throughout drilling is required to ensure drill bit integrity.¿ a review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints of this nature have been confirmed.No abnormalities were reported with this product during manufacture.No further investigation is warranted at this time.(b)(4).

Event Description

It was reported that during a labral repair using a fastener, fixation, nondegradable, soft tissue, that metal flakes came out of the drill guide, and were suctioned out of the joint.A back up device was available to complete the case and there were no reported patient injuries or complications.A backup device was available to complete the surgery.(b)(4).

• Brand Name: TWIST DRILL,FLEX,CRVD, FOR 2.3 SA
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5010197
• MDR Text Key: 24529413
• Report Number: 1219602-2015-00845
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2019
• Device Catalogue Number: 72203160
• Device Lot Number: 50517428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1