MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB-BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202623
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the 4.5 mm twinfix ultra pk anchor broke while hammered.It is unknown if all fragments were retrieved from the patient.A back-up device was used to complete the procedure, but it is unknown if another bone hole had to be drilled.The surgery was not delayed.The patient was not harmed.
Additional Manufacturer Narrative
One 72202623 twinfix ultra pk 4.5mm suture anchor reported due to unavailability, 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.Influences that could compromise product performance or integrity include: unexpected bone condition/density.Alternate method than technique driven instructions for use.Incomplete anchor insertion.Loss of or lack of axial alignment.Per ifu: ¿caution: use of 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 hole size and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the hole size to achieve optimal insertion force.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¿.Maintaining axial alignment is critical to successful implantation.Tapping of the awl dilator is the recommended method.Final product met predetermined specifications upon release to distribution.There were no other complaints for this lot.
Additional Manufacturer Narrative
One 72202623 twinfix ultra pk 4.5mm suture anchor was used for treatment and returned for evaluation.Device damage was confirmed.The anchor was fractured and split open.The metal of the inserter neck was twisted.The inserter tip was fractured.Both forks were absent, but eventually located within the broken suture inside the anchor cavity.Symptoms indicate excess torque and force were primary causes.Loss of axial alignment was secondary from hammering.The intent is to ¿tap¿ the awl dilator for a starter pilot hole to screw the anchor into.Per ifu ¿caution: use of excessive force during insertion can cause failure of the suture anchor or insertion device.If more torque is required to insert the anchor, stop and ensure that the hole size and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the hole size to achieve optimal insertion force.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¿.Maintaining axial alignment is critical to successful implantation.Tapping of the awl dilator is the recommended prep method.Complaint history review indicated no similar allegations for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: TWINFIX ULTRA PK 4.5MM W/2 UB-BL &BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9164827
• Report Number: 1219602-2019-01219
• Device Sequence Number: 2151994
• Product Code: MBI
• UDI-Device Identifier: 03596010647528
• UDI-Public: 03596010647528
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2020

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: 09/27/2023
• Device Model Number: 72202623
• Device Catalogue Number: 72202623
• Device Lot Number: 2021383
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/05/2019; 01/26/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/07/2019; 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1