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	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the top of the anchor broke off.No patient injury reported.
Additional Manufacturer Narrative
One (b)(4) twinfix ti 5.0 preloaded suture anchor device returned.The complaint stated: "it was reported that the top of the anchor broke off inside the patient." four tainted needles and associated sutures were returned wrapped around device shaft.The driver and anchor have attained much visible damage.The damages are consistent with a force and torsional overload factors.Instructions for use are quite specific and instruct two finger ao technique use.Caution: excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.If more torque is required to insert the anchor, stop and ensure that the drill bit size and depth are correct." proper site prep includes pre-drilling which is essential for successful use of the device.The appropriate smith & nephew drill bit and drill guide are each sold separately.There is obvious visible distortion of the female steel hex driver insertion shaft.It has been completely twisted and collapsed at the distal end.The titanium anchor has been fractured at the male hex head and has multiple gouges on the threads that are symptoms of inadvertent contact with other instruments or devices.The proximal portion of hex head and thread chips were not returned.No functional evaluation could be performed due to the damages attained.There are no other complaints for this production lot.No root cause related to the manufacture of this device was confirmed.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.

• 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: 7652944
• Report Number: 1219602-2018-00854
• Device Sequence Number: 13840627
• Product Code: MBI
• UDI-Device Identifier: 03596010532206
• UDI-Public: (01)03596010532206(17)220808(10)50678969
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2018

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: 08/08/2022
• Device Model Number: 7210708
• Device Catalogue Number: 7210708
• Device Lot Number: 50678969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 10/23/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/03/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1