MAUDE Adverse Event Report: ARTHROCARE CORP. DOUBLE FIX KNOTLESS PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72290143
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International zip code: (b)(6).
Event or Problem Description
It was reported that during articular labrum repair/arcr procedure, the tip of inserter was checked and found broken off.The broken tip was confirmed at x-ray.Remaining parts of the screw (of the inserter) were retrieved but other parts were remained in the patient.There was a 30 minute delay and the procedure was finished with the same device.
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.Visual inspections of the instrument show no manufacturing abnormalities.The implant was detached and the device was returned with the not damaged implant attached in a separate plastic bag.No sutures were returned with the instrument.The parts returned show no manufacturing abnormalities.The returned double fix knotless pk is a single used device and cannot be functional tested.The complaint was not verified and the root cause could not be determined with certainty.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.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.) 3b-related: c-(b)(4), c-(b)(4), and c-(b)(4) it was reported that the metal tip of the inserter ¿remains in the implanted anchor and it could not be removed.¿ based on asdm and iso standards, the inserter material composition would fall into a standardized medical grade alloy and, although not approved for implantation, standardized alloys have not been determined to cause injury or harm when the duration of contact with tissues/blood/bone is short-term.Imaging to confirm location of the device within the shoulder has not been provided; however, per communication, the inserter tip/fragment was confirmed via x-ray to be retained within the anchor.It is unknown if micro-motion could occur.It was reported that the procedure was completed with the same device within a 30 minute surgical extension with no harm to the patient.The patient¿s post-operative condition and if any intervention is anticipated to remove the fragment and/or anchor is unknown at this time.Per the product evaluation, no manufacturing abnormalities were noted and the separately returned implant (screw-portion/invibio peek optima lt3) was not damaged; however, functional testing could not be performed due to the device being a ¿one-time use¿ instrument.In conclusion: based on the information provided, the root cause of the retained ¿remainder of the inserter¿ could not be concluded.The patient¿s post-operative condition and if any intervention is anticipated to remove the foreign body fragment and/or anchor is unknown at this time.Future patient impact beyond possible localized irritation/discomfort and/or dislodgement/micro-motion/migration of the retained inserter tip cannot be determined.No further medical assessment can be rendered at this time.
Additional Manufacturer Narrative
The initial incident report was submitted with incorrect manufacturing site registration number (b)(4).The correct manufacturing site registration number is (b)(4).

• Brand Name: DOUBLE FIX KNOTLESS PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8153115
• Report Number: 1219602-2018-01728
• Device Sequence Number: 2165950
• Product Code: MBI
• UDI-Device Identifier: 00885556722497
• UDI-Public: 00885556722497
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2020

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 Model Number: 72290143
• Device Catalogue Number: 72290143
• Device Lot Number: 2020671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/28/2019; 02/08/2020
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/29/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1