MAUDE Adverse Event Report: ARTHREX, INC. UNIVRSAL REVERSE HUMERAL PROTECTOR S; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-9509-S
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	02/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.No device malfunction can be identified.At this time, it cannot be determined how the device may have caused or contributed to the incident.An evaluation of the device cannot be performed as the device remained in the patient.Lot number was not provided so device history record review cannot be performed.Should the device be returned or additional information become available it will be reported in a supplemental report.Facility retaining - available on site.
Event or Problem Description
It was reported via medwatch (b)(4).That during a total shoulder arthroplasty procedure a humeral head protector, ar-9509-s, was utilized to ensure the humeral head did not fracture.It was reported that the humeral head protector slipped behind the shoulder into the deltoid muscle, out of site of the surgeon.The wound was closed and the patient was discharged.Upon surgeon reviewing the post-op x-ray it was discovered that the humeral head protector had been retained in the wound.The patient was scheduled to return to the or for device removal.This information was reported under cc114972 (medwatch 1220246-2017-00190).Additional information obtained (b)(6) 2017: original procedure was (b)(6) 2017.Revision procedure was (b)(6) 2017.During the revision only the humeral head protector, ar-9509-s, was explanted.Per customer device will not be returned but is available on site for evaluation if needed.

• Brand Name: UNIVRSAL REVERSE HUMERAL PROTECTOR S
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6615171
• Report Number: 1220246-2017-00200
• Device Sequence Number: 10918690
• Product Code: LXH
• UDI-Device Identifier: 00888867061606
• UDI-Public: 00888867061606
• 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: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/06/2017

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 Catalogue Number: AR-9509-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/06/2017
• 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