MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE ARTHRO-PIERCE; ARTHROPIERCE INSTRUMENT, CURVED LEFT

Model Number 72201186

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2013

Event Type  malfunction  

Event Description

During a shoulder arthroscopy procedure it was reported that when the surgeon opened the punch, it broke.Two pieces fell down in the joint and only one could be removed.The patient has been informed by the surgeon.There were no clinical consequences reported post-op.This reusable device was manufactured two months prior to the procedure and it is unknown if it was previously used or this was the initial use of the device.A back-up device was available to complete the procedure.

Manufacturer Narrative

The customer indicates the device will not be returned for analysis.(b)(4).

• Brand Name: ARTHRO-PIERCE
• Type of Device: ARTHROPIERCE INSTRUMENT, CURVED LEFT
• Manufacturer (Section D): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3938063
• MDR Text Key: 4572904
• Report Number: 1219602-2014-00209
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201186
• Device Catalogue Number: 72201186
• Device Lot Number: 50478895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/23/2013
• Device Age: 2 MO
• Event Location: Other
• Date Manufacturer Received: 02/25/2014
• Date Device Manufactured: 10/17/2013
• 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