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

Catalog Number 7209874

Device Problem Break (1069)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the procedure the guidewire broke and a piece (about 3 centimeters) was unable to be retrieved.The piece was left in the patient.According to the report the patient has an allergy to nickel which is one of the materials of the guidewire.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided and no relevant clinical information was received to assist in the evaluation.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6337828
• MDR Text Key: 67647264
• Report Number: 1219602-2017-00208
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

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: 08/23/2021
• Device Catalogue Number: 7209874
• Device Lot Number: 50617442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• 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): Other