MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX MALLET *EA; SURGICAL MALLET

Model Number	213705
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the sales rep in (b)(6) that during an unknown surgery on an unknown date, it was observed that the handle on the rigidfix mallet device came off the surgeon's hand.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: b5: subsequent follow-up with the customer, additional information was received about the event; therefore, the event description has been updated to reflect this additional information.
Event or Problem Description
It was reported by the sales rep in united kingdom that during an arthroplasty procedure on an unknown date, it was observed that the handle on the rigidfix mallet device came off the surgeon's hand.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary background: the mallet¿s handle has come off in surgeon¿s hands during the procedure.Investigation summary: the rigidfix mallet *ea (part #: 213705, lot #: unk) was received and evaluated at us cq.Upon visual inspection, the mallet handle broke off the head.There were scratches observed on the both the faces of the mallet head.Hence, the reported condition can be confirmed.The possible root cause for the reported condition can be that the device encountered unintended forces during its use.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.

• Common Device Name: SURGICAL MALLET
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11486035
• Report Number: 1221934-2021-00845
• Device Sequence Number: 14306018
• Product Code: LXH
• UDI-Device Identifier: 10886705002993
• UDI-Public: 10886705002993
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/01/2021

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: 213705
• Device Catalogue Number: 213705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 04/15/2021; 05/05/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 03/22/2021; 04/16/2021; 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1