MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. SLOTTED MALLET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MAL-0920-085-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tsa surgery, the plastic piece one (1) slotted mallet broke and flied off while in use.The procedure was resumed, without any delay, using a competitor device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the product has not been returned to the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Visual inspection: visual inspection was unable to be performed because the device has not been received for evaluation.The complaint does not allege any injury nor a delay in surgery.As the device has not been returned for evaluation, it could not be determined whether the device contributed to the reported event.As the device has not been returned for evaluation, a definitive root cause could not be determined.The slotted mallet is a reusable instrument expected to be used across multiple surgeries.The mallet features a face made of acetal plastic and is used to impact other devices to assist with insertion or removal during surgery.Potential causes for the reported instrument breakage include incorrect surgical technique and normal wear and tear.The mallet may have been subjected to excessive force during impaction.Alternatively, the failure may be the result of wear on the instrument due to normal use as the instrument is reusable.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• Brand Name: SLOTTED MALLET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16690862
• Report Number: 3002788818-2023-00028
• Device Sequence Number: 12599432
• Product Code: LXH
• UDI-Device Identifier: 00885556861141
• UDI-Public: 00885556861141
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: MAL-0920-085-01
• Device Catalogue Number: MAL-0920-085-01
• Device Lot Number: 280906-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/18/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown