MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE ACORNREAM 6MM THIN *EA; CANNULATED SURGICAL DRILL

Model Number	219336
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.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 affiliate in (b)(6) that a 6mm acorn reamer device was bent and got stuck inside a handpiece device.There was no procedure nor patient involvement 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.Investigation summary: according to the information received, it was reported by the sales rep via complaint submission tool that the 6mm acorn reamer is bent and got stuck inside a non-mitek device.The complaint device is not being returned, therefore unavailable for a physical evaluation.Given that lot number was not provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.This complaint cannot be confirmed.Since the complaint device not being returned, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11170263
• Report Number: 1221934-2021-00104
• Device Sequence Number: 19524501
• Product Code: HTO
• UDI-Device Identifier: 10886705005819
• UDI-Public: 10886705005819
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 12/16/2020

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: 219336
• Device Catalogue Number: 219336
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1