MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 10MM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72203331
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery, when the endobutton continuous loop was removed from the packet, it was found that it was already frayed.The procedure was completed without delay using a back-up device.No patient injury 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 reported 10mm endobutton cl, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the continuous loop was found to be frayed when removed from the packaging an exact root cause cannot be determined with confidence without the return of the device; however, factors that could have contributed to the reported event include: over handling of the device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
H10 h3, h6: one endobutton cl ultra 10mm not used in treatment, has been returned for evaluation.The information provided states: ¿during an unknown surgery, when the endobutton continuous loop was removed from the packet, it was found that it was already frayed¿.Visual assessment confirms complaint.The loop was frayed.An exact root cause cannot be determined with confidence.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.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.No further investigation is warranted.

• Brand Name: ENDOBUTTON CL ULTRA 10MM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10335522
• Report Number: 1219602-2020-01138
• Device Sequence Number: 2865162
• Product Code: GAT
• UDI-Device Identifier: 00885554028546
• UDI-Public: 00885554028546
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2020

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: 05/11/2023
• Device Model Number: 72203331
• Device Catalogue Number: 72203331
• Device Lot Number: 50734969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 09/15/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/30/2020; 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1