MAUDE Adverse Event Report: ETHICON INC. GUT CHROMIC SUTURE 18"(45CM) 4-0 UND; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1654G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what measures were taken to retrieve the broken piece? the needle broke into 2 pieces and both ends were seen and retrieved.Was there any additional tissue damage as a result of searching for the needle piece? no.Were x-rays taken to locate the needle piece(s)? both pieces were found, but xrays.Were taken as a precaution to insure no fragments were left.At what location was the needle found? perineal area (operative area).Was the patient brought back to operating room to have needle removed or was the needle removed during the initial procedure? retrieved during initial procedure.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 the patient underwent a debridement of peritoneum enclosure procedure and suture was used.During the procedure, the tip of the needle broke off.The tip was found and retrieved.It was unknown how the suture was being used at the time of needle breakage.Procedure was completed with another suture of the same product code.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The actual device was returned for evaluation.Upon evaluation, a fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.  there is no evidence of any material flaw that would cause premature failure.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).

• Brand Name: GUT CHROMIC SUTURE 18"(45CM) 4-0 UND
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7266187
• Report Number: 2210968-2018-70822
• Device Sequence Number: 1823221
• Product Code: GAL
• UDI-Device Identifier: 10705031001626
• UDI-Public: 10705031001626
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2018

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: 02/28/2022
• Device Catalogue Number: 1654G
• Device Lot Number: LCM110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 03/26/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/26/2018; 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1