MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GD WIRE,NITINOL,1.2 X 45CM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72202998
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery when the nitinol guide pin was placed, it was broken, and was removed without causing damage to the patient.Finally a backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
One 1.2mmx45cm nitinol guidewire was returned for evaluation.Visual assessment of the device confirmed its reported breakage.Approximately 3.5 inches of its length has been broken off.The broken portion was not returned for examination.The break area shows no material voids.The break area does show significant signs of elastic deformation.The guidewires condition indicates it was subjected to excessive force during 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.No root cause related to the manufacturing process can be established.No further investigation is warranted at this time.

• Brand Name: GD WIRE,NITINOL,1.2 X 45CM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7713946
• Report Number: 1219602-2018-00901
• Device Sequence Number: 19086563
• Product Code: LXH
• UDI-Device Identifier: 00885554017670
• UDI-Public: (01)00885554017670(17)230223(10)50716467
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2018

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: 02/23/2023
• Device Model Number: 72202998
• Device Catalogue Number: 72202998
• Device Lot Number: 50716467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 10/09/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/21/2018; 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1