MAUDE Adverse Event Report: ARTHROCARE CORP. MINIMAGNUM KNOTLESS IMPLANT PKG; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	OM-2500
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an open shoulder stabilization 3 speedstitch sutures failed to deploy/be captured by the needle.Assembly was supervised by a s&n rep and other sutures deployed properly.Mini magnum anchor failed to deploy.It seemed that the snare wire broke early during initial suture reduction or tensioning after anchor insertion but before wing deployment.Other mini magnum anchors were used without issues.Medical intervention was necessary, surgeon had to revert to traditional suture passing through the labrum instead of using speedstitch device.
Additional Manufacturer Narrative
The reported minimagnum knotless implant device, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, ¿mini magnum anchor failed to deploy.It seemed that the snare wire broke early during initial suture reduction or tensioning after anchor insertion but before wing deployment.¿ customer¿s complaint was confirmed.The three suture cartridge and black/white cobraid suture were returned in used condition.No manufacturing discrepancies observed.The speedstitch suture cartridge is a single use device and functional test is not possible.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) improper suture loading, (2) excessive tensioning or (3) improper alignment of the inserter handle with the bone hole.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The instruction for use states: -the implant system requires tension to be distributed through both suture legs to achieve suture lock deployment.The use of a locking suture stitch (i.E.Modified mason-allen) may cause tensioning to be more difficult due to the inability of the suture legs to move freely through the tendon.- use care to properly align the implant and inserter handle with the bone hole while inserting the implant into the bone hole.Do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No serious injury reported.
Event or Problem Description
It was reported that during an open shoulder stabilization, during the deployment of the mini magnum, the customer stated that the snare¿s suture broke early during initial suture reduction or tensioning after anchor insertion, before wing deployment.The customer had to revert to traditional suture passing through the labrum which is an equivalent technique.Other mini magnum anchors were used without issues.No injuries or delays were reported.

• Brand Name: MINIMAGNUM KNOTLESS IMPLANT PKG
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8910067
• Report Number: 3006524618-2019-00406
• Device Sequence Number: 13504224
• Product Code: MBI
• UDI-Device Identifier: 00817470005592
• UDI-Public: 00817470005592
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042584
• 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): 10/03/2019

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 Expiration Date: 01/11/2020
• Device Catalogue Number: OM-2500
• Device Lot Number: 1175424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1