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

Catalog Number	219124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the devices were received and evaluated.Visual observation revealed that all three devices had broken distal tips, confirming the complaint.The root cause could not be definitively determined as the specific details regarding the sterilization process were not provided.Typically, this type of failure can be attributed to normal wear and tear of the device after heavy use and multiple sterilization cycles.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point, 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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).The lot number is unknown.
Event or Problem Description
The sales rep reported that prior to unknown procedure on an unknown date during sterilization the tip of three of their screw/wash hex drivers 2.5mm broke off.The sales rep stated that the devices broke prior to being used on the patient.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep could not provide lot numbers for these devices.The sales rep was not present for the case therefore could not provide any further information.The devices will be returning for evaluations.

• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8352118
• Report Number: 1221934-2019-56435
• Device Sequence Number: 2229160
• Product Code: LXH
• UDI-Device Identifier: 10886705005420
• UDI-Public: 10886705005420
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 219124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2016
• Initial Report FDA Received Date: 02/19/2019
• Patient Sequence Number: 1