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 Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).(b)(4).

Event Description

It was reported that the knot was difficult to slide down the sutures and the healicoil sa pk 5.5mm pulled out while tightening the knot.There was a reported short delay of less than 30 minutes.No patient injury was reported in association with this event.

Manufacturer Narrative

Device investigation narrative - one 5.5 mm pk sa healicoil anchor assembly was returned for evaluation.Visual assessment of device shows two of the three lengths of suture are missing from the anchor and were not returned for examination.The remaining piece of suture shows no abnormalities.The inserter shows no damage.The anchor is bent and the outer most proximal thread is cracked.Dimensional assessment of the anchor confirmed it meets print specifications.With the limited clinical details provided regarding patient bone quality and site preparation no root cause can be determined.No root cause related to the manufacturing process can be established.Further investigation is not warranted at this time.(b)(4).

• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5748002
• MDR Text Key: 48846741
• Report Number: 1219602-2016-00317
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

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 Expiration Date: 07/24/2020
• Device Catalogue Number: 72203380
• Device Lot Number: 50558887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• 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