MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,ACROMIOBLASTER,5.5MM,DSPL BLADE; SOFTWARE, MANAGEMENT, MICROPLATE ASSAY

Catalog Number 7211026

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Awaiting receipt of device.

Event Description

It was reported the tweezers broke inside the patient.No delay in the case was noted.

Manufacturer Narrative

Due to no product being returned the complaint could not be confirmed.Evaluation and investigation are not possible.No definitive conclusions can be made without pertinent manufacturing information or a device to evaluate.See communications for timeline.No further actions can be taken at this time.If relevant information becomes available to assist with traceability, the complaint will be revisited.

• Brand Name: MTO,ACROMIOBLASTER,5.5MM,DSPL BLADE
• Type of Device: SOFTWARE, MANAGEMENT, MICROPLATE ASSAY
• 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: jim gonzales ; 7000 w. william cannon; austin, TX 78735
• MDR Report Key: 6612018
• MDR Text Key: 76760742
• Report Number: 3003604053-2017-00062
• Device Sequence Number: 1
• Product Code: MTO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7211026
• Device Lot Number: LT2614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1