MAUDE Adverse Event Report: ARTHREX, INC. PERC INSERT KIT FOR 3.0 MM KNOTLESS ST; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PERC INSERT KIT FOR 3.0 MM KNOTLESS ST
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the nitinol wire bent and broke when the guide was removed from the patient.A partial wire, about 2" was left in the patient.The patient is to return on (b)(6) 2020 to have it removed.Went to take the guide out and it bent.There was no rep in the case, patient is male; labrum case.Additional information obtained 2/13/20: the wire fragment was successfully removed on (b)(6) 2020 with no complications.

• Brand Name: PERC INSERT KIT FOR 3.0 MM KNOTLESS ST
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9706017
• Report Number: 1220246-2020-01664
• Device Sequence Number: 3675735
• Product Code: MDM
• UDI-Device Identifier: 00888867271647
• UDI-Public: 00888867271647
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 11/30/2024
• Device Model Number: PERC INSERT KIT FOR 3.0 MM KNOTLESS ST
• Device Catalogue Number: AR-1938PK
• Device Lot Number: 10503302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/13/2020
• 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