MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ALL-SUTURE INLINE DRILL GUIDE SPIKE TIP, XL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203845

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2014

Event Type  malfunction  

Manufacturer Narrative

Subject device was returned for evaluation.Visual inspection confirmed failure mode of ¿shedding/flaking¿.Rings were observed on the flute of the drill and inside the tip of the guide.No other anomalies were observed.In addition to a visual assessment, the total indicated runout, outer diameter of the drill and the inner diameter of the drill guide were inspected.All dimensions were within specification.A review of the device history records was performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.A complaint history review has not identified additional complaints for the manufactured lot number on file.Per results of the investigation, no root cause could be determined.At this time, no further investigation will be implemented.(b)(4).

Event Description

During a hip arthroscopy, labral repair procedure utilizing the all-suture inline drill guide spike tip, xl, it was reported that there was shedding of the drill against the guide.It was reported that the shedding occurred while the surgeon was drilling into the bone.It was reported that all debris was removed from patient by use of a shaver and suction.Backup device was available to complete the procedure.It was reported that the patient condition post-surgery was satisfactory.(b)(4).

• Brand Name: ALL-SUTURE INLINE DRILL GUIDE SPIKE TIP, XL
• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5004423
• MDR Text Key: 24308495
• Report Number: 1219602-2015-00758
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203845
• Device Lot Number: 50486849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2013
• 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
• Patient Weight: 86