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

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

It is unknown if there was patient involvement.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.No service history review can be performed as part number 319.006 with lot number(s) 5252431 is a lot/batch controlled item.The manufacture date of this item is (b)(6) 2006.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a depth gauge has a broken needle.It is unknown how and where this occurred.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Part 319.006, lot 5252431: release to warehouse date: june 08, 2006.Manufactured by synthes (b)(4).Review of the device history records (dhr) showed there are potential issues during the manufacture of the product that would contribute to this complaint condition.A non-conformance report was written for various lots including 5252431 an undersized major diameter of the thread feature on the needle component.As the complaint description notes that the needle failed, relevance to the complaint condition cannot be determined until the product is returned for investigation; however, the bending strength of an external thread element would be a function of the size of the minor diameter, not the major diameter since the minor diameter represents the worst case cross section in terms of bending strength.All subcomponent dhrs were reviewed and found to be without issue during the manufacturing process that would contribute to this complaint condition.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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6022484
• MDR Text Key: 57272829
• Report Number: 2530088-2016-10287
• Device Sequence Number: 1
• Product Code: HTJ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• 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: 5252431
• Other Device ID Number: (01)10886982189943(10)5252431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2006
• 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