MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE WR 1.2MM X 12" BOX OF 5 STERILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7211138
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery, x-rays were performed and it was found that a broken tip of guidewire remained in the patient, so the patient was taken back to surgery on the same day to remove the broken piece.No further information is available about the patient and the outcome of the surgery.
Additional Manufacturer Narrative
One 1.2mm nitinol guidewire was returned for evaluation.Visual assessment of the device confirmed its reported breakage.Approximately 1.190 of its distal has been broken off.The break area shows no material voids.The break area shows significant signs of elastic deformation.The broken portion is bent on two planes the guidewire condition indicates it was subjected to excessive forces resulting in its failure.Excessive forces applied to the instrument can result in failure.

• Brand Name: GUIDE WR 1.2MM X 12" BOX OF 5 STERILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7820769
• Report Number: 1020279-2018-01650
• Device Sequence Number: 1249197
• Product Code: LXH
• UDI-Device Identifier: 03596010559050
• UDI-Public: (01)03596010559050(17)211219(10)50637243
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: 7211138
• Device Catalogue Number: 7211138
• Device Lot Number: 50637243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention