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

Model Number	IPN013965
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
No injuries, patient unharmed, head sheared off at junction of handle.
Event or Problem Description
No injuries, patient unharmed, head sheared off at junction of handle.
Additional Manufacturer Narrative
(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.(1) sample of km46666 was received for evaluation with lot # j9.Visual review of the device noted impact marks on the edge of the mallet face with off center striking.The mallet head has sheared from the handle.The device is not functional in current state.The recent samples for broken handles will be sent to the eic for review with the supplier.(1) sample of km46666 was received for evaluation with lot # j9.Visual review of the device noted impact marks on the edge of the mallet face with off center striking.The mallet head has sheared from the handle.A dimensional inspection was not required as part of this investigation.The device is not functional in current state.A small number of complaints have been received across multiple lots.E6, a9, f9, d4, j9, 20032366, 20033862, 20034170, 20037331, 20037516, 20039172, 20039509, 20039579, 20040182, 20040251 sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to km46666.No corrective actions are warranted at this time, but the failed devices will be reviewed with the supplier to make them aware.

• 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: 12569041
• Report Number: 3011137372-2021-00264
• Device Sequence Number: 4053587
• Product Code: HXL
• UDI-Device Identifier: 24026704272222
• UDI-Public: 24026704272222
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/22/2021
• 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