MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	SMM-5044
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter intra-operatively in a mastopexy procedure, during the internal closure of the breast, the device needle broke and fell into the patient.The fragment was later retrieved.The incision was extended because the distal end of the needle was lost in the body fat.There was also an extension of surgical time.The patient is doing okay.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The fragment was later retrieved with their hands.There was also an extended time in the surgery by more than 30 minutes due to the product problem.The patient is doing okay.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of four devices.The visual inspection and functional evaluation of the sample had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
Event or Problem Description
According to the reporter intra-operatively in a mastopexy procedure, during the internal closure of the breast, the device needle broke and fell into the patient.The fragment was later retrieved with their hands.The incision was bigger because the distal end of the needle was lost in the body fat.There was also an extended time in the surgery by more than 30 minutes due to the product problem.The patient is doing okay.

• Brand Name: MAXON
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; north haven
• MDR Report Key: 6760925
• Report Number: 1219930-2017-06136
• Device Sequence Number: 11022529
• Product Code: GAM
• UDI-Device Identifier: 10884523004649
• UDI-Public: 10884523004649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: SMM-5044
• Device Catalogue Number: SMM-5044
• Device Lot Number: B4G1020X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 07/28/2017; 01/10/2018
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 08/25/2017; 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other