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

Model Number	72203331
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the threads of the endobutton were found to be torn; the procedure was successfully 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
H3, h6 h10: one 72203331 10mm ultra cl endobutton used in treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.Factors affecting device performance include: device ability, surgical ability and conformance with instructions for use (ifu) 10600961 which includes recommendations and precautionary statements for proper use of product.If further information becomes available may be revisited.The nature of the filament material is extremely fine.Disruption and fluffing is inherent to its fine nature and may occur upon removal from its package.The fiber is sensitive to excess handling.This condition is defined as a perceived flaw.There is no detriment to safety, efficacy or design intent.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.
Additional Manufacturer Narrative
H10 h3,h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned with the sutures in their original position.The loop appeared to have minor frays and was partially unraveled.There was some debris on the sutures.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the reported event include greater loop manipulation or handling than anticipated or contact with sharp edges of the bone graft.

• 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: 10499558
• Report Number: 1219602-2020-01361
• Device Sequence Number: 13529065
• Product Code: GAT
• UDI-Device Identifier: 00885554028546
• UDI-Public: 00885554028546
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K980155
• 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,Followup
• Report Date (Section B): 03/12/2021

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: 07/30/2023
• Device Model Number: 72203331
• Device Catalogue Number: 72203331
• Device Lot Number: 50749617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/11/2020; 10/11/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 10/12/2020; 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR