MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PITBULL JR.; ACCESSORIES,ARTHROSCOPIC

Catalog Number	014845
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ankle arthroscopy procedure, the device broke off.Pieces were removed from patient.Is unknown if a backup device was available.No delay and no patient injuries were reported.
Additional Manufacturer Narrative
The reported pitbull jr.Intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: PITBULL JR.
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9106299
• Report Number: 1219602-2019-01158
• Device Sequence Number: 1776260
• Product Code: NBH
• UDI-Device Identifier: 03596010026705
• UDI-Public: 03596010026705
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 014845
• Device Lot Number: 50751543
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1