MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 12IN 3-0 SA PS PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B110
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: please clarify that part of the needle broke the needle did not break.The suture itself detached from the needle.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? there were no unexpected outcomes.The surgery was only delayed ~2-3 minutes.Patient¿s current status? the patient was not impacted by this event.Please provide procedure date (b)(6) 2020.Please provide lot number, qbb8dm.Status of product return follow up, product will be sent next week.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unicompartmental knee arthroplasty on (b)(6) 2020 and a barbed suture was used.During the procedure, the needle broke off suture while closing subcuticular layer.The suture itself detached from the needle.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 11/20/2020.Additional information: d10, h6.Corrected information: d4 - unknown.Corrected h-6 device codes: 1069.Additional h-3 summary: a failed suture needle was submitted for fractographic evaluation.The component was identified as product code sxmp1b110.A fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.The manufacturing records could not be reviewed as the batch number is invalid.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SFX SPI MCRYL+ UNI 12IN 3-0 SA PS PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10534343
• Report Number: 2210968-2020-06891
• Device Sequence Number: 3872904
• Product Code: GAM
• UDI-Device Identifier: 10705031236639
• UDI-Public: 10705031236639
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N12159
• 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): 09/02/2020

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 Model Number: SXMP1B110
• Device Catalogue Number: SXMP1B110
• Device Lot Number: QBB8DM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1