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

Catalog Number	7209874
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the surgery 1 nitinol guidewire broke inside the patient, all the pieces were removed with a grasper, the second one worked without any problems.There was a delay of 10 minutes no patient injury reported.
Additional Manufacturer Narrative
One 1.2mm nitinol guidewire from a disposable hip pak kit was returned for evaluation.Visual assessment of the device confirmed its reported breakage.Approximately 2.622 of its length has been broken off.No material voids were observed at the break area.The break area shows significant signs of elastic deformation.The guidewire is also bent on multiple planes.The guidewires condition indicates it was subjected to excessive forces resulting in its failure.Per the device instruction for use under ¿precautions¿ as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.No root cause related to the manufacturing process can be established.
Event or Problem Description
It was reported that during the surgery 1 nitinol guidewire broke inside the patient, all the pieces were removed with a grasper.The procedure was successfully completed without any significant delay using a back-up device.No patient injury or other complications were reported.

• Brand Name: HIP PAC DISPOSABLE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9152587
• Report Number: 1219602-2019-01196
• Device Sequence Number: 2694149
• Product Code: NBH
• UDI-Device Identifier: 03596010529596
• UDI-Public: 03596010529596
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 7209874
• Device Lot Number: 2024853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1