MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS WITH ARTHROSCOPIC DELIVERY; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	4403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rotator cuff repair procedure, the bone anchor broke.The piece was not removed from the patient.Backup device was available to complete the procedure.No significant delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.An analysis of the customer provided image found one of the tines on the inserter have been broken.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the instructions for use found excessive force applied during tendon anchor deployment may result in damage to the tissue, to the material being fixated, to the anchor, or to the tendon anchor inserter.A review of risk management files found that the reported failure was documented appropriately.Clinical evaluation found that no further medical assessment is warranted at this time.The complaint was confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.
Additional Manufacturer Narrative
Medwatch report number: (b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair procedure, the bone anchor broke.The piece was looked for in the surgical site and thoroughly irrigated.Risk of going into the patient to remove far outweighed the benefits.Backup device was available to complete the procedure.No significant delay and no patient complications were reported.

• Brand Name: BONE ANCHORS WITH ARTHROSCOPIC DELIVERY
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10452136
• Report Number: 3003604053-2020-00090
• Device Sequence Number: 17214234
• Product Code: MBI
• UDI-Device Identifier: 00854501006159
• UDI-Public: 854501006159
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K131635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2020

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 Catalogue Number: 4403
• Device Lot Number: 2048689
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 09/02/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/24/2020; 10/08/2020
• 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: Required Intervention