MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FEMORAL AWL 45°; BONE AWL

Model Number	219313
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi:(b)(4).The lot number was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.Investigation summary the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.No lot numbers were supplied which precludes conducting a dhr review or a lot of specific search in the complaints handling system.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot no lot numbers were supplied which precludes conducting a dhr review or a lot of specific search in the complaints handling system.
Event or Problem Description
It was reported by the customer that during an unknown surgery on an unknown date, it was observed that the tip on the restore femoral awl 45° device was broken.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: RESTORE FEMORAL AWL 45°
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15149126
• Report Number: 1221934-2022-02315
• Device Sequence Number: 5748171
• Product Code: LXH
• UDI-Device Identifier: 10886705005680
• UDI-Public: 10886705005680
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 219313
• Device Catalogue Number: 219313
• 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: 07/16/2022
• Initial Report FDA Received Date: 08/02/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown