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

Catalog Number 7209874

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

A visual inspection of the device confirmed the reported breakage.A three inch portion of the guidewire has broken off and was not returned.An examination of the break area shows signs of plastic deformation.The guidewire appears to have been bent so dramatically during use that it broke under the excessive force placed on it.No root cause related to the manufacture of the device can be established.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

It was reported that a two inch segment of the guidewire which is included in the disposable hip pac broke off inside a patient.The piece was removed with the use of a grasper.A backup guidewire was used to complete the procedure.No patient injury or other complications were reported.

• 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: jim gonzales ; 150 minuteman road; andover, MA 01810
• MDR Report Key: 5972692
• MDR Text Key: 55702262
• Report Number: 1219602-2016-00921
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2015

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: Other
• Device Expiration Date: 09/08/2020
• Device Catalogue Number: 7209874
• Device Lot Number: 50564778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1