MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TF ULTRA 2 UBRAID AND NDLS 5.5MM PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202615
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a shoulder rotator cuff repair surgery, the non-bioabsorbable twinfix ultra suture anchor tip broke while inserted into the patient bone.A back-up was available and used in the same bone hole.All fragments were removed from the patient.There was a surgical delay of less than 30 min.No patient injuries have been stated.For preparation of the insertion site, it was used a 3.8 mm gold dilator; patient bone quality was described as hard.
Additional Manufacturer Narrative
One 72202615 twinfix ultra pk 5.5mm suture anchor reported on.Product was not returned for evaluation.Due to unavailability, the allegation could not be fully confirmed.Full investigation and conclusions were not possible without physical evaluation.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: non-compliance or deviation from technique driven instructions.Alternate prep method or instruments used.Unexpected bone density/condition.Incomplete anchor insertion.Loss of or lack of axial alignment.Hard bone was reported.Product met specifications upon release to distribution.

• Brand Name: TF ULTRA 2 UBRAID AND NDLS 5.5MM PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8308585
• Report Number: 1219602-2019-00141
• Device Sequence Number: 16626655
• Product Code: MBI
• UDI-Device Identifier: 03596010656209
• UDI-Public: 03596010656209
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 08/02/2023
• Device Catalogue Number: 72202615
• Device Lot Number: 50750662
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR