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

Model Number 72203380

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 10/03/2017

Event Type  malfunction  

Event Description

It was reported that, while tying down suture after anchor was implanted in the bone, and suture was passed, the eyelet that secures all the suture broke.All the suture came loose and part of the anchor broke in the bone.The remaining part of the broken anchor was removed.No patient injury reported.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Bone quality.

• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6918657
• MDR Text Key: 89482685
• Report Number: 1219602-2017-01244
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554026313
• UDI-Public: (01)00885554026313(17)210315(10)50591513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2021
• Device Model Number: 72203380
• Device Catalogue Number: 72203380
• Device Lot Number: 50591513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• 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