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	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Instrument damaged due to poor quality.Mallet heads have deformed shape.Further 2 of these have actually broken from the stem, one happened in theatre which is very dangerous to staff and patient if actually it hit someone.
Additional Manufacturer Narrative
Qn#(b)(4).(1) sample of km46666 lot f9 (july 2019) was received for evaluation.Visual inspection of the mallet faces shows heavy wear on the handle side of the mallet face from off center impact.The face of the mallet has rolled over the edge and eibits deep cracks and splits around the expanded metal.The visual appearance of this device should have removed it from use before this level of damage occurred.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to km46666.Mallet head is made of a 300 series "deformable" stainless steel.This material is not hardenable which is intentional.Precipitation hardened steels can potentially explode on heavy impact creating extreme risk to patients and physicians.All teleflex instrument ifus for reuseable devices require inspection for cracks and other defects prior to use and clearly specifies removal from service.The samples received from this customer exhibit heavy wear and off center striking.Despite the excessive wear the handle union remains intact for this device.Additional complaints from the same customer: customer have exhibited detached mallet heads post deformation of the mallet face showing repeated and continued use against ifu advisements.(1) sample of km46666 lot f9 (july 2019) was received for evaluation.Visual inspection of the mallet faces shows heavy wear on the handle side of the mallet face from off center impact.The face of the mallet has rolled over the edge and eibits deep cracks and splits around the expanded metal.The visual appearance of this device should have removed it from use before this level of damage occurred.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.Previous complaints include (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 km46666 the samples received from this customer exhibit heavy wear and off center striking.Despite the excessive wear the handle union remains intact for this device.Additional complaints from the same customer: customer have exhibited detached mallet heads post deformation of the mallet face showing repeated and continued use against ifu advisements.Mallet head is made of a 300 series "deformable" stainless steel.This material is not hardenable which is intentional.Precipitation hardened steels can potentially explode on heavy impact creating extreme risk to patients and physicians.All teleflex instrument ifus for reuseable devices require inspection for cracks and other defects prior to use and clearly specifies removal from service.
Event or Problem Description
Instrument damaged due to poor quality.Mallet heads have deformed shape.Further 2 of these have actually broken from the stem, one happened in theatre which is very dangerous to staff and patient if actually it hit someone.

• 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: 12342100
• Report Number: 3011137372-2021-00220
• Device Sequence Number: 3887320
• 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): 08/04/2021

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: KM46666
• Device Lot Number: F9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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