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

Model Number	7211138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an acl reconstruction surgery, the guide tip broke in two during the insertion of the biosure regenesorb screw.Both pieces were successfully retrieved using tweezers.There was a delay of under 30 min and the procedure was completed using a s+n backup device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 7211138 1.2mmx45cm nitinol guidewire, used in treatment, has been returned for evaluation.From the information provided, the guidewire broke during use.Visual assessment confirms breakage of guidewire.Guidewire was broken in three places.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the device during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

• 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 blvd.; mansfield MA 02048
• MDR Report Key: 10424714
• Report Number: 1219602-2020-01274
• Device Sequence Number: 2963300
• Product Code: LXH
• UDI-Device Identifier: 03596010559050
• UDI-Public: 03596010559050
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: 7211138
• Device Catalogue Number: 7211138
• Device Lot Number: 2044736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 10/05/2020
• 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