MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MAXON CV; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	6124-21
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the operation went smoothly during a concealed penis lengthening procedure.The patient then used a synthetic absorbable surgical suture to suture the skin but half of the needle broke in the skin.The broken needle was difficult to be found in the skin so an x-ray was taken.After the location was determined, the broken needle was found and removed.The operation was then continued.It was stated that surgical time was extended sine it took about 50 minutes from the breaking of the needle to the removal of it.

• Brand Name: MAXON CV
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 11477310
• Report Number: 1219930-2021-01021
• Device Sequence Number: 14411771
• Product Code: GAM
• UDI-Device Identifier: 10884523002072
• UDI-Public: 10884523002072
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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 Model Number: 6124-21
• Device Catalogue Number: 6124-21
• Device Lot Number: D6D0258X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/12/2021
• 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: Required Intervention
• Patient Age: 12 YR