MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH

Catalog Number 319.006

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a synthes sales representative.Part 319.006, lot h249554: release to warehouse date :april 07, 2017.Supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was completed: visual inspection of the complaint device showed that the slider is smoothly-running.Furthermore, the handle as well as the black colored parts have discoloration areas.The needle is slightly bent.All features related to the reported complaint condition were reviewed and no other issues were identified.The device was reassembled/ assembled without any functional issue detected.The slider is smoothly-running.The reported issue could not be reproduced.Dimensional inspection showed the relevant dimensions were conforming.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Our investigation has shown that the complaint condition is unconfirmed as the reported issue could not be reproduced.Nevertheless, the complaint will be rated as confirmed due to the damages incurred.However, the findings above let us exclude a manufacturing related issue.For the bending issue, it is possible that the device encountered unintended forces such as being dropped during usage or handling.Due to the age and the strong used condition of the device, we do assume that the device underwent several cleaning and sterilization procedures over the years.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the depth gauge was delivered to the hospital.When the hospital staff checked it, it was found that the depth gauge was about to came off at its neck.The substitute product was delivered to the hospital.During investigation by the manufacturer, it was noted that the needle is slightly bent.This report is for a depth gauge.This is report 2 of 2 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10960288
• MDR Text Key: 220236140
• Report Number: 8030965-2020-09467
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819707238
• UDI-Public: (01)07611819707238
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: H249554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 12/08/2020
• Patient Sequence Number: 1
• Treatment: DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T.