MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,ARTHRO-PIERCE INSTR STRGHT; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7210378

Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the bottom jaw of the device broke off in the patient.The broken piece was removed from the patient.A backup device was available to complete the procedure following a short delay to retrieve the broken fragment.No patient impact was reported.

Manufacturer Narrative

Due to no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: MTO,ARTHRO-PIERCE INSTR STRGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7118526
• MDR Text Key: 95069048
• Report Number: 1219602-2017-01545
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 7210378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1