MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S PEEK 5.5MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	OM-2300
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/10/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery, the patient had a right shoulder adhesive capsulitis on (b)(6) 2016.The event was treated with physical therapy and patient had a s/p r shoulder scope, sad, lysis of adhesions, capsular release and muga on (b)(6) 2016.The outcome of the patient is recovered.
Additional Manufacturer Narrative
The reported multifix s peek 5.5mm device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: physical conditions that would eliminate or tend to eliminate adequate implant support or retard healing.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Will proceed with a medical assessment based on clinical supporting documents provided.If no relevant medical information is provided can close the mi task.Approved by justin templeton, md a review of relevant clinical medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information surgical procedure/post-operative care review ,device labeling (including technique guides, ifus, etc.) no relevant clinical medical information was provided to conduct a thorough medical assessment.

• Brand Name: MULTIFIX S PEEK 5.5MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8814676
• Report Number: 3006524618-2019-00347
• Device Sequence Number: 13533014
• Product Code: MBI
• UDI-Device Identifier: 00817470000580
• UDI-Public: 00817470000580
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: OM-2300
• Device Lot Number: 1124533
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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: Other