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

Catalog Number	4403
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision rcr using regeneten implant the nurse have difficulty capturing tendon anchors from puck.On the retrival 3 tendon anchors broke while trying to load them.The anchors snapped before being removed from the puck.The distal tip of inserter was slightly skewed after initial use.Then a second bone anchor was opened to spare the tendon anchor puck, it was used a new inserter and the tendor anchors broke again when loading.The surgeon use the remaining anchors 1-2 short of his preference, and the needle and suture in order to finish securing the implant.A delay of 5 minutes were reported.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3,h6: 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.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 prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 10524489
• Report Number: 3003604053-2020-00102
• Device Sequence Number: 19612536
• Product Code: MBI
• UDI-Device Identifier: 00854501006159
• UDI-Public: 854501006159
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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 Catalogue Number: 4403
• Device Lot Number: 2044104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1