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Patient 1
(B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE MH2224, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: A SUTURE NEEDLE WAS RETURNED FOR EVALUATION. A FRACTURE WAS OBSERVED IN THE BODY OF SAMPLE A. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) 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 OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. MECHANICAL DAMAGE, A CUP-AND-CONE SHAPED FRACTURES AND MACROSCOPIC PLASTIC DEFORMATION OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS 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 INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DATE OF THE INITIAL SURGICAL PROCEDURE (NORMAL DELIVERY SURGERY). 2020.1.14. WAS THE INITIAL PROCEDURE A C-SECTION OR VAGINAL DELIVERY? VAGINAL DELIVERY. REGARDING THE FIRST NEEDLE BROKEN WHEN GRIPPING OUT OF THE PATIENT?S BODY: WHAT IS THE PRODUCT CODE AND LOT NUMBER OF THE DEVICE THAT BROKE ?WHEN GRIPPING OUT OF THE PATIENT?S BODY?? VCP442H/LOT MJ7022. DID THE NEEDLE BREAK DURING USAGE OR DID THE NEEDLE BREAK PRE-OP BEFORE USE ON THE PATIENT? THE NEEDLE BREAK DURING SURGERY WHEN GRIPPING BEFORE USED ON PATIENT. WAS THERE A REPORTED ISSUE WITH THE 5 PIECES THAT ARE BEING RETURNED? IF YES, PLEASE DESCRIBE THE SPECIFIC DEVICE ISSUE FOR EACH OF THE 5 DEVICES BELOW: VCP358H, LOT JE2698 (1 PC). VCP442H, LOT MJ7022 (2 PCS). VCP442H, LOT MH2224 (2 PCS). NO ISSUE REPORTED FOR NOW, BUT DUE TO CONTINUOUSLY BREAKAGE NEEDLE ISSUE IN THIS SURGERY, THE HOSPITAL REQUEST US TO RETURN THEM TO INSPECT THE NEEDLE IF THEY ARE ANY PROBLEM WITH THE NEEDLE WHICH WILL BE EASY TO BREAK. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE: FEMALE. ON WHAT TISSUE WAS THE SUTURE USED? PERINEAL SKIN. WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? NORMAL. WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? NEEDLE HOLDER. WHERE WAS THE NEEDLE GRASPED DURING USE? POSTERIOR 1/2 OF THE MIDDLE OF THE NEEDLE. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS: UNKNOWN. WHAT IS PHYSICIAN?S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? QUALITY ISSUE WITH THE NEEDLE. WHAT IS THE PATIENT?S CURRENT STATUS? HAS BEEN DISCHARGED. NOTE: EVENTS REPORTED VIA MW FOR 2 PIECES INVOLVED IN THE SURGERY: 2210968-2020-01428 (SAMPLE C), 2210968-2020-01429 (SAMPLE B). ADDITIONAL DEVICES REPORTED VIA MW 2210968-2020-02383 (SAMPLE A), 2210968-2020-02381 (SAMPLE D), 2210968-2020-02382 (SAMPLE E).