MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/3 UB-BL, CBBL,LT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203380

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2015

Event Type  malfunction  

Manufacturer Narrative

Only the 5.5 healicoil sa pk inserter was returned for evaluation.Visual assessment of the device showed no damage.The distal tip was examined using a stereo microscope for any evidence of burrs or displaced material, no observations were made.Functional inspection of the device found it operates as intended.The ¿silver ring¿ was not returned for evaluation and as such, we are unable to determine a root cause for the reported incident.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that after inserting anchor into patient the healthcare professional pulled the inserter out of the patient and noticed a silver ring floating in the patient's shoulder.Metal ring was removed.Anchor is in the patient.Device was returned.No damage noted to the inserter.There was no difficulty/ unexpected issues while inserting the anchor.Healthcare professional was confident that no piece/debris was left in the patient.Anchor was fully inserted and used to complete the procedure.No other complications were noted.

• Brand Name: HEALICOIL SA PK 5.5MM W/3 UB-BL, CBBL,LT
• 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: 5957241
• MDR Text Key: 55175175
• Report Number: 1219602-2016-00639
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 72203380
• Device Lot Number: 50481755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1