MAUDE Adverse Event Report: ARTHREX, INC. SCORPION NEEDLE, HIP LENGTH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SCORPION NEEDLE, HIP LENGTH
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The probable cause of the event could not be determined from the information available and without device evaluation.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
It was reported that during a hip labral repair, the tip of the ar-16991n broke off when passing suture; it was not retrieved from the patient.The case was completed; the patient is a (b)(6) female.

• Brand Name: SCORPION NEEDLE, HIP LENGTH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11842611
• Report Number: 1220246-2021-03117
• Device Sequence Number: 3831161
• Product Code: LXH
• UDI-Device Identifier: 00888867189362
• UDI-Public: 00888867189362
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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: 12/31/2022
• Device Model Number: SCORPION NEEDLE, HIP LENGTH
• Device Catalogue Number: AR-16991N
• Device Lot Number: 10182195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1