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

Catalog Number	7209874
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the guide wire snapped upon insertion through capsule.The device break inside the patient and was not removed.A backup device was used to complete the surgery.
Additional Manufacturer Narrative
Foreign zip code: (b)(4).One (b)(4) disposable hip pac reported on.The complaint stated: ¿it was reported that the tip of the guide wire snapped upon insertion through capsule.¿ product was not returned for evaluation.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1.Getting entangled up with other instruments or devices.2.Use of other that recommended smith & nephew drill.3.The primary cutting edges of the drill are not sharp or have dings and burrs.4.Stressed product from over torque or loss of axial alignment.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Per instructions for use: ¿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¿.Final product met predetermined specifications upon release to distribution.Updated.
Event or Problem Description
It was reported that during surgery the tip of the guide wire snapped upon insertion through capsule.The device break inside the patient and was not removed.A backup device was used to complete the surgery.

• 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: 8064525
• Report Number: 1219602-2018-01530
• Device Sequence Number: 11234541
• Product Code: NBH
• UDI-Device Identifier: 03596010529596
• UDI-Public: 03596010529596
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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: 03/30/2023
• Device Catalogue Number: 7209874
• Device Lot Number: 50724142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1