MAUDE Adverse Event Report: DEPUY MITEK LLC US SCR/WASH DEPTH GAUGE *EA; SURGICAL DEPTH GAUGE, REUSABLE

Model Number	219024
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4) - incomplete.
Event or Problem Description
It was reported via email by the sales rep that his n/c replacement device has the same failure as his original complaint ((b)(4)) which was the customer's depth gauge is measuring 4-5mm incorrectly.Sales rep provided a photo.This device is being returned.
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.The manufacturer contact name has been updated as (b)(4).Contact phone number and email address have been updated accordingly.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.

• Common Device Name: SURGICAL DEPTH GAUGE, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7694202
• Report Number: 1221934-2018-53746
• Device Sequence Number: 11095171
• Product Code: LXH
• UDI-Device Identifier: 10886705005390
• UDI-Public: (01)10886705005390(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: 219024
• Device Catalogue Number: 219024
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1