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	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an anterior cruciate ligament surgery, when the package was opened, it was noticed the sterile package of the "1.2mm x 30cm guide wire" was not sealed properly.Although the surgery was not delayed, it is unknown if a back-up device was available to complete the procedure.No patient injuries or other 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 device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.Factors that are known to contribute to the alleged fault/failure may be shipping damage, a component failure, or handling.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product is returned in the future the complaint can be reopened and evaluated.

• 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: 10442950
• Report Number: 1219602-2020-01298
• Device Sequence Number: 3872542
• Product Code: LXH
• UDI-Device Identifier: 03596010559050
• UDI-Public: 03596010559050
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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: 05/09/2024
• Device Model Number: 7211138
• Device Catalogue Number: 7211138
• Device Lot Number: 2033203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1