MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 30IN 2-0 S/A PS-1 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	EH7550H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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.
Event or Problem Description
It was reported that a patient underwent a spinal procedure on (b)(6) 2020 and suture was used.During the procedure, the suture appeared to be unraveled or frayed.Surgery completed with same like product.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device batch pdh838, number and no non-conformances were identified.Additional h3 device evaluation summary: it was received for analysis an opened box with twenty-six unopened samples of product code eh7550h, lot pdh838.The complaint sample was not returned for evaluation.During the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problem and examined, no defects, damage or fraying suture along of the strands were observed.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance ¿ fraying suture was found.Representative samples returned to support investigation of device issues captured in reports mw 2210968-2020-00755 and 2210968-2020-00756.Analysis results have been included in follow up reports for each.

• Brand Name: PROLENE BLU 30IN 2-0 S/A PS-1 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9638334
• Report Number: 2210968-2020-00755
• Device Sequence Number: 19561564
• Product Code: GAW
• UDI-Device Identifier: 10705031096981
• UDI-Public: 10705031096981
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133356
• 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): 01/09/2020

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: 03/31/2024
• Device Model Number: EH7550H
• Device Catalogue Number: EH7550H
• Device Lot Number: PDH838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1