MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72203706

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A visual inspection of the device confirmed its breakage.The anchor was returned in ten multiple length pieces.A dimensional assessment is unattainable due to the anchors condition.No root cause related to the manufacturing process can be established.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during the insertion of the 5.5mm healicoil rg sa it crumbled into multiple pieces.No patient injury or other complications were reported.

• Brand Name: HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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 ; 5123585706
• MDR Report Key: 5970209
• MDR Text Key: 55693274
• Report Number: 1219602-2016-00849
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• PMA/PMN Number: K123393
• 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
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 72203706
• Device Lot Number: 50589053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1