MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP PAC, DISPOSABLE; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209874

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

During a hip arthroscopy it was reported that the doctor was trying to gain access into the hip joint and was pushing the cannula with obturator over the needle and a piece of the needle broke off.The piece appeared to be about two to three centimeters in length.The length was too long while the surgeon was pushing the cannula over it, therefore it broke.This also occurred with a second needle from the same kit.They eventually converted to an open procedure to remove the needles.The doctor said the patient is okay.A backup device was available to complete the procedure.There was a delay of about an hour or more before they decided to open.The site has indicated that nothing will be returned for analysis.

Manufacturer Narrative

The device has not been returned.Due to the device not being returned, we are unable to determine what may have caused the user to experience the reported incident.A review of the device history records was performed which confirmed no inconsistencies.A complaint history review identified no additional complaints for this manufactured lot.In the event the sample is returned for evaluation the complaint will be reopened for additional investigation.No further investigation is necessary at this time.(b)(4).

• Brand Name: HIP PAC, DISPOSABLE
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5163526
• MDR Text Key: 28830044
• Report Number: 1219602-2015-01082
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2020
• Device Catalogue Number: 7209874
• Device Lot Number: 50543213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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
• Patient Outcome(s): Required Intervention