MAUDE Adverse Event Report: DEPUY MITEK LLC US SCR/WASH HEXDRV 2.5MM *EA; SURGICAL SCREWDRIVER, REUSABLE

Model Number	219124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information provided, this complaint has been created in order to document the blind device received with product code #: unk -driver / lot/serial #:unknown.The device was received and evaluated.Visual observations reveal that distal tip of the shaft driver was found broken.In addition, the handle and the press pin were not presented physical damages.When pictures were taken under magnification, anomalies cannot be observed in the structure of the shaft driver.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures or can be attributed to excessive force was exerted at an off angle on the device causing it to break.However, this cannot be conclusive determined.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.
Event or Problem Description
This complaint has been created in order to document the blind device received with product code #: unk -driver / lot/serial #:unknown.No information is available regarding the patient details or hcp.

• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10760310
• Report Number: 1221934-2020-03277
• Device Sequence Number: 19662653
• Product Code: LXH
• UDI-Device Identifier: 10886705005420
• UDI-Public: 10886705005420
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 219124
• Device Catalogue Number: 219124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/30/2020
• Patient Sequence Number: 1