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

Model Number	7209874
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guide wire snapped off in the tissue surrounding the capsule.No patient injuries were reported.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6933282
• Report Number: 1219602-2017-01280
• Device Sequence Number: 13758991
• Product Code: NBH
• UDI-Device Identifier: 03596010529596
• UDI-Public: (01)03596010529596(17)220725(10)50676578
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1