MAUDE Adverse Event Report: CP MEDICAL POLYPROPYLENE; POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE,,

Model Number	8682P-CP1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that size 4/0 polypropylene suture broke during normal procedure.The distributor has been contacted several times and hasn't provided details of the event.The only known information is the product number.(8682p) either lot# 190425-56 or lot# 181227-54 is associated with the event.Testing and investigation was completed on both lots for documentation purposes.If additional information is received a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Report amended to refelect test results from issue sample.- attachment: [lot# 181227-54 retain sample tensile test.Pdf, lot# 181227-54 return sample tensile test.Pdf].
Event or Problem Description
It was reported that size 4/0 polypropylene suture broke during normal procedure.The distributor has been contacted several times and hasn't provided details of the event.The only known information is the product number.(8682p) either lot# 190425-56 or lot# 181227-54 is associated with the event.Testing and investigation was completed on both lots for documentation purposes.If additional information is received a supplemental mdr will be submitted.Amendment: testing and investigation was completed per issue lot# 181227-54.

• Brand Name: POLYPROPYLENE
• Common Device Name: POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE,,
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 9131344
• Report Number: 3012164473-2019-00024
• Device Sequence Number: 14074400
• Product Code: GAW
• UDI-Device Identifier: 10790986003559
• UDI-Public: 10790986003559
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K001185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 11/30/2023
• Device Model Number: 8682P-CP1
• Device Catalogue Number: 8682P-CP1
• Device Lot Number: 181227-54
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1