MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	7210708
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the twnfx ti 5.0 str anchr w/2 ultrb str n, the first anchor was entered in the bone on the patient¿s ankle without problems, by the surgeon.The second one broke when entering the bone in the ankle.It occurred when the tip of the anchor was inside the patient.The tip was left inside the bone in the patient.The surgeon is an experienced user of twinfix.No patient harm or death.The device will be returned for evaluation.
Additional Manufacturer Narrative
One ed7210708 twinfix titanium 5.0 preloaded suture anchors with two ultrabraid suture needles returned.The device is used.Records say that there were two anchors being used and the second one failed during insertion.No portion of anchor was returned.The delivery device was returned damaged.There are four needles and associated sutures remaining in place within the device handle storage areas.The insertion shaft has obvious distortion of the steel shaft.The damage is focused at the second horizontal indicator line.The condition is consistent with loss of axial alignment and having excess force applied.It was not relayed whether the recommended prep occurred.No root cause related to the manufacture of the device was established.

• Brand Name: TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7194232
• Report Number: 1219602-2018-00076
• Device Sequence Number: 13706713
• Product Code: MBI
• UDI-Device Identifier: 03596010532206
• UDI-Public: (01)03596010532206(17)211221(10)50637730
• Combination Product (Y/N): N
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2021
• Device Model Number: 7210708
• Device Catalogue Number: 7210708
• Device Lot Number: 50637730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1