MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH

Catalog Number 319.006

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

F the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part: ,319.006, lot: ft00388.Supplier: (b)(4), release to warehouse date: mar 02, 2017.No non conformance reports were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no relevant non-conformance noted.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Visual inspection observed broken needle on the returned depth gauge.The broken needle portion was not returned at customer quality.However, all other portions of depth gauge i.E.; protection sleeve, body and slider were returned.No other issues were identified on the remaining portions of the device except for the signs of wear that doesn't affect product functionality.The device condition agree with the complaint description and the complaint was confirmed.Relevant drawings for the returned device were reviewed, and no design issues were noted.Dimensional inspection was not possible as the relevant broken portion was not returned.While no definitive root cause could be determined, it is possible that any unintended excessive forces such as device being dropped during usage/handling could have contributed to complaint condition.The overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

It was reported that on (b)(6) 2018, while inspecting the instruments before putting the sets back together, it was found that the tip of the depth gauge was broken and missing.It is unknown how the device issue occurred.There was no patient involvement as reported.This report is for one (1) depth gauge.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8027955
• MDR Text Key: 125777469
• Report Number: 2939274-2018-54730
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• 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: FT00388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1