MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72202602

Device Problem Bent (1059)

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

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

Device investigation narrative - one 5.5 twinfix ultra plla/ha anchor assembly was returned for evaluation.Visual assessment confirmed the reported breakage.The distal tip of the anchor has broken at the suture eyelet.Dimensional assessment of the anchors major diameter found it within print specifications.With the limited clinical details regarding patient bone quality and site preparation, a root cause cannot be determined.Further investigation is not required at this time.(b)(4).

Event Description

It was reported that the device tip bent during insertion without any pressure being applied.Additional information received from the device investigation indicated that the device was broken.

Manufacturer Narrative

(b)(4).

• Brand Name: TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/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: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7053134
• MDR Text Key: 93075841
• Report Number: 1219602-2017-01460
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Catalogue Number: 72202602
• Device Lot Number: 50658583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2017
• 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