MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE ELITE PASS NEEDLES; TRUEPASS NEEDLE,SINGLE PACK

Model Number 72203793

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

During a rotator cuff repair, the tip of the needle broke off.Tip was not retrieved.Post op x-rays were taken however the surgeon said he was not able to locate the broken piece for certain.It was confirmed that the x-rays are not available for review and that the sales rep was present.Back-up device was available.

Manufacturer Narrative

There is no product returning for device analysis.(b)(4).

Manufacturer Narrative

Device not being returned for evaluation.No root cause found- no sample.(b)(4).

• Brand Name: ELITE PASS NEEDLES
• Type of Device: TRUEPASS NEEDLE,SINGLE PACK
• 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: 4008916
• MDR Text Key: 4779273
• Report Number: 1219602-2014-00243
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203793
• Device Catalogue Number: 72203793
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2014
• Event Location: Hospital
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1