MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE ARTHRO-PIERCE; ARTHROPIERCE 45 DEG RIGHT

Model Number 7209497

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/04/2014

Event Type  malfunction  

Manufacturer Narrative

The device was returned missing the entire front end assembly.The front end was not returned for evaluation.The device was visually evaluated and the actuator shaft was confirmed to be bent and out alignment.Additionally the tip of the outer shaft of the front end assembly is broken.The site was examined via microscope at (b)(4).The damage is consistent with twisting and bending at that location.In addition, the center slot walls of the outer shaft that the actuator rests in are observed to be splined.Per ifu ¿do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿ (b)(4).

Event Description

During an arthroscopic bankart repair the customer reported that the sharp part (1.5mm) of the tip broke off.The surgeon tried to retrieve the tip by scoping with a probe however, was unable to remove the piece from the patient.There was a bony part in the tissue of the labrum and that is where the tip broke.The procedure was able to be completed with a backup device.It was reported that the patient was okay post procedure.Patients bone quality was reported as good.

Manufacturer Narrative

Although anticipated, the device has not been received for analysis.(b)(4).

• Brand Name: ARTHRO-PIERCE
• Type of Device: ARTHROPIERCE 45 DEG RIGHT
• 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: 3973420
• MDR Text Key: 15638562
• Report Number: 1219602-2014-00227
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/04/2014

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 Model Number: 7209497
• Device Catalogue Number: 7209497
• Device Lot Number: T807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/04/2014
• Device Age: 7 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2007
• 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
• Patient Age: 17 YR