MAUDE Adverse Event Report: TELEFLEX MEDICAL ORTHO. MALLET 2 LB/ 1 LB

Model Number	IPN013965
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument broke during procedure while being used.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Instrument broke during procedure while being used.
Additional Manufacturer Narrative
Qn# (b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to km68834.(1) sample of km69834 lot b9 (feb 2019) was received for evaluation with a broken plug extractor.The plug extractor is used to clear the inner cannula after a plug has been cut outside of the surgical field.The welded seam between the plug extractor handle and shaft has separated.Visual inspection of the handle noted an impact mark to matches the plug cutter orifice.This impact likely contributed to the broken device.The plug cutter is still functional but the handle for the plug remover hinders removal of a cut plug.Isolated incident with no risk to the patient.(1) sample of km69834 lot b9 (feb 2019) was received for evaluation with a broken plug extractor.The plug extractor is used to clear the inner cannula after a plug has been cut outside of the surgical field.The welded seam between the plug extractor handle and shaft has separated.Visual inspection of the handle noted an impact mark to matches the plug cutter orifice.This impact likely contributed to the broken device.A dimensional inspection was not required as part of this investigation.The plug cutter is still functional but the handle for the plug remover hinders removal of a cut plug.There are no other complaints for this product in the history of sap dating back to 2007.No confirmed complaints were received in this range with the same issue for the product family.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to km68834.Isolated incident with no risk to the patient.
Event or Problem Description
Instrument broke during procedure while being used.

• Brand Name: ORTHO. MALLET 2 LB/ 1 LB
• Common Device Name: MALLET
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13632755
• Report Number: 3011137372-2022-00037
• Device Sequence Number: 2174503
• Product Code: HXL
• UDI-Device Identifier: 24026704272222
• UDI-Public: 24026704272222
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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 Model Number: IPN013965
• Device Catalogue Number: KM69834
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown