MAUDE Adverse Event Report: DEPUY MITEK LLC US 23MM HEX DRIVER W/TEARDROP HANDLE -NS; SURGICAL SCREWDRIVER, REUSABLE

Model Number	270127
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by sales rep that during an anterior cruciate ligament reconstruction surgery on (b)(6) 2021, it was observed that the 23mm hex driver w/teardrop handle device was bent.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
The lot number was unknown; therefore, the manufacturing site name was unknown.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.
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:visual observations revealed that the drive was bent on the distal part, which confirms the customer complaint.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.The complaint device was received and evaluated.Visual observations revealed the distal portion of the hex driver is deformed.This type of failure is consistent with device being dropped or hitting other metal instruments or excess force being exerted while use on the device.Other than this possibility, a root cause is undetermined for this reported failure.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.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.
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: the complaint device was not returned; therefore, unavailable for a physical evaluation.However, a photo was provided.Visual observations revealed that the drive was bent on the distal part, which confirmed the customer complaint.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.The photo did not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The root cause for the bent condition could be attributed to technique issue where excess mechanical force was applied, which could have led to the reported failure, and the heavily use of the device since this is a reusable part.As per ifu, inspect for damage prior to use; and replace a damaged, worn or bent instrument.Also, the end of useful instrument life is generally determined by wear or damage from handling or surgical use.Inspect instruments between uses to verify proper functioning.Finally, it is necessary to follow the instructions and warnings of any cleaning and disinfection agents and equipment used; also, the recommendation of the proper condition during the sterilization and maintenance to avoid any damage.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.

• Brand Name: 23MM HEX DRIVER W/TEARDROP HANDLE -NS
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13225932
• Report Number: 1221934-2022-00128
• Device Sequence Number: 4064646
• Product Code: LXH
• UDI-Device Identifier: 10886705014033
• UDI-Public: 10886705014033
• Combination Product (Y/N): N
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 270127
• Device Catalogue Number: 270127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 01/26/2022; 01/27/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 01/27/2022; 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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