MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA TI 4.5 W/2 UB (WH & BLUE); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202893
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure due to bad quality the anchor expired and it was fully removed.No delay and back up was available to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
One 72202893 twinfix ultra ti 4.5mm suture anchor used for treatment, was not returned for evaluation.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were limited.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Final product met predetermined specifications upon release to distribution.
Additional Manufacturer Narrative
One 72202893 twinfix ultra ti 4.5mm suture anchor device used for treatment, was returned for evaluation.The complaint stated: ¿due to bad (¿bone poroson¿) quality the anchor expired and it was fully removed.¿ the patient¿s bone condition was inadequate for this product application.Insertion device and anchor were returned.The anchor had small segments of cut suture inside.The main suture lengths were absent.The anchor was not damaged.The insertion device was not damaged.There was no observation that would support product failure.Recommended prep instruments are a spade drill tip and a tapered awl.Instructions for use for this product has technique driven instructions and cautions: ¿it is the responsibility of the surgeon to determine the patient's bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and bone/tissue condition.Instruction for use documentation is quite specific and confirms instructions, precautionary statements and recommendations for proper use of product.No root cause related to the manufacture of this device was confirmed.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
Additional information: adverse event.Correction: serious injury.Event: it was reported that during a revision surgery due to bad quality the anchor expired and it was fully removed.No delay and back up was available to complete the procedure.No patient injury was reported.
Event or Problem Description
It was reported that during a revision surgery due to bad quality the anchor expired and it was fully removed.No delay and back up was available to complete the procedure.No patient injury was reported.

• Brand Name: TWINFIX ULTRA TI 4.5 W/2 UB (WH & BLUE)
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8881907
• Report Number: 1219602-2019-00946
• Device Sequence Number: 242319
• Product Code: MBI
• UDI-Device Identifier: 03596010652287
• UDI-Public: 03596010652287
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2024
• Device Catalogue Number: 72202893
• Device Lot Number: 2025109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 09/26/2019; 10/31/2019
• Initial Report FDA Received Date: 08/11/2019
• Supplement Report FDA Received Date: 08/27/2019; 10/01/2019; 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR