MAUDE Adverse Event Report: DEPUY MITEK LLC US MODULAR DRV 30MM; SURGICAL SCREWDRIVER, REUSABLE

Model Number	219958
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Udi: (b)(4).Incomplete the lot number is unknown at this time.
Event or Problem Description
It was reported via complaint submission tool that during a knee arthroscopy it was noted that a 30mm modular driver - biocomposite had a wrong description lasered.It is written 2,5mm instead of 30mm.No surgical delay or patient consequences reported.Additional information provided by the affiliate reported a surgical delay did not occur and the case was completed with the same device as an alternative was not available.There were no reported patient consequences.
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: d10, 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
Product complaint # (b)(4).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: investigation summary: according to the information provided, it was reported that during a knee arthroscopy it was noted that a 30mm modular driver - bio-composite had a wrong description lasered.It is written 2,5mm instead of 30mm.The complaint device was received and evaluated.Visual observations and visual inspections on the picture provided confirm that the laser marks etched on the screwdriver was found incorrect.According with drawing of the device the correct etch is 30mm instead of 2,5mm.The manufacturer was contacted, since the device did not include the lot number information and the symbol that was marked in the device was not consistent with paragon's markings, as result the failure was not related to paragon manufacturing.The complaint can be confirmed.We cannot discern a root cause for this failure.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.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.Udi:(b)(4).The lot number is unknown.

• Brand Name: MODULAR DRV 30MM
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10684805
• Report Number: 1221934-2020-03012
• Device Sequence Number: 3110508
• Product Code: LXH
• UDI-Device Identifier: 10886705007011
• UDI-Public: 10886705007011
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 09/28/2020

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: 219958
• Device Catalogue Number: 219958
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 12/08/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/03/2020; 12/09/2020
• Patient Sequence Number: 1