MAUDE Adverse Event Report: ROTATION MEDICAL, INC. BONE ANCHORS 3 W ARTHRO DEL SYSTEM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72205200

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

It was reported that, while performing the rotator cuff repair surgery, the outside cannula (sheath) of the bone anchor inserter did not retract completely and the bone punch pins remained stuck to the regeneten implant.This caused the regeneten implant to rip in half.A new set was used and the bioinductive implant was taken out and replaced by a new one.Surgery was not delayed more than 30 min.The patient was not harmed beyond the reported event.

Manufacturer Narrative

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.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.A review of the instructions for use found inserting the bone anchor through excessive soft tissue and failing to engage the anchor into bone may not provide adequate fixation.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.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYSTEM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th ave. no. suite 100; plymouth MN 55447
• MDR Report Key: 10343473
• MDR Text Key: 201434550
• Report Number: 3009351468-2020-00008
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556733479
• UDI-Public: 885556733479
• Combination Product (y/n): N
• PMA/PMN Number: K131635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CN: 72205197. LN: 27879
• Patient Outcome(s): Required Intervention