MAUDE Adverse Event Report: ARTHREX, INC. PERC INSERT KIT FOR 2.9MM P-LCK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PERC INSERT KIT FOR 2.9MM P-LCK
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
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.It was reported that the customer will not be returning the device.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 ar-1923pk was being used for a slap repair on a (b)(6) male patient.The guide wire broke after going through the cuff.The broken piece was removed; it required a small additional incision about an inch below the lateral incision to retrieve the broken piece.The case was completed with a pushlock anchor.

• Brand Name: PERC INSERT KIT FOR 2.9MM P-LCK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8344401
• Report Number: 1220246-2019-00898
• Device Sequence Number: 13911801
• Product Code: LXH
• UDI-Device Identifier: 00888867096745
• UDI-Public: 00888867096745
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/15/2019

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: 06/30/2023
• Device Model Number: PERC INSERT KIT FOR 2.9MM P-LCK
• Device Catalogue Number: AR-1923PK
• Device Lot Number: 10222610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/15/2019
• 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
• Patient Age: 47 YR