MAUDE Adverse Event Report: SMITH & NEPHEW, 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	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during procedure, the white cap of the slotted mallet broke off.The procedure was resumed, without any delay by changing the surgical technique.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H6: the product has not been received at 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 product family.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.- 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.- dhr/batch record review: dhr/batch review could not be performed as the product lot information was not provided.- visual inspection: a visual inspection could not be performed as the device was not returned.The complaint alleges no injury to the patient nor a delay during surgery.It is expected that the device contributed to the reported event as the most probable cause is fracture due to applying excessive force during impaction.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 further corrective action is not indicated as no non-conformances or 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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed that the acetal white material was completed fractured off of the main device from the internal section of where the materials meet.The missing material was not returned with the device.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed part number over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SLOTTED MALLET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16429520
• Report Number: 1020279-2023-00396
• Device Sequence Number: 12090004
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2025

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: UNKNOWN
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/30/2023; 03/26/2025
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/31/2023; 03/28/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown