MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72200755

Device Problem Component Falling (1105)

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

Event Date 04/05/2017

Event Type  malfunction  

Event Description

It was reported that during a a left rotator cuff repair surgery, when first inter anchor was implanted, the press component of shaft fell suddenly,and couldn't be used any more.The anchor had to be removed from the patient.No reported patient injuries.No other complications were noted.

Manufacturer Narrative

Visual assessment of the device confirmed the reported complaint of disassembly.The nose cone, sliding ring and spring have come free from the handle, spring was not returned.Examination of the nose cone showed the tabs that interface with the handle have broken off.The condition of the device indicates excessive force was placed on it during use.Potentially the cause for this device failure was excessive forces were applied to the instrument, causing a result in failure.After the evaluation the root cause for the reported issue was determined to be user error.A review of the device history records and complaint files confirmed that no additional complaints have been reported and no abnormalities were noted during the manufacturing process for this lot.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• 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 w. william cannon; austin, TX 78735
• MDR Report Key: 6520589
• MDR Text Key: 73796734
• Report Number: 1219602-2017-00425
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200755
• Device Lot Number: 50547320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 54 YR
• Patient Weight: 65