MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP PAC DISPOSABLE; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7209874
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the guide pin broke off inside the patient.The broken piece was attempted to be removed arthroscopically but ended up by opening.This caused a delay greater than an hour.No other patient injury was reported and the surgeon was able to continue the case with a different guide pin with no problem.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.

• Brand Name: HIP PAC DISPOSABLE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8475265
• Report Number: 1219602-2019-00376
• Device Sequence Number: 11242919
• Product Code: NBH
• UDI-Device Identifier: 03596010529596
• UDI-Public: 03596010529596
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2023
• Device Catalogue Number: 7209874
• Device Lot Number: 2024880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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: 30 YR