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

Model Number 7209874

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

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

Event Date 10/03/2017

Event Type  malfunction  

Event Description

It was reported that the guide wire snapped off in the tissue surrounding the capsule.No patient injuries were reported.

Manufacturer Narrative

Visual assessment of the device confirm that has broken.Approximately 3.25 inches of the guidewire has broken off and was not returned for evaluation.The break area shows the guidewire was bent to failure, which indicates the guidewire was subjected to excessive force during use.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.

• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6933282
• MDR Text Key: 89752404
• Report Number: 1219602-2017-01280
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010529596
• UDI-Public: (01)03596010529596(17)220725(10)50676578
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: 7209874
• Device Catalogue Number: 7209874
• Device Lot Number: 50676578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 11/16/2017
• Supplement Dates FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• 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