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

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.No patient involvement reported.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Device history records review was conducted for: part # 319.006, lot #6702113.Release to warehouse date: 27jun2011.Expiration date: na.Manufactured by: (b)(4).Relevance to complaint condition cannot be determined until the product is returned for investigation.Part 319.006 lot #6702113 contained ncr (b)(4) for an undersized major diameter of the thread feature on the needle component.As the complaint description notes the gauge is bent and most likely on the verge of breaking, the location of the bent was not reported.The review of the device history records(s) showed that there are potential issues during manufacture of the product what would contribute to this complaint condition.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 on an event in (b)(6) as follows: it was reported that the tip broke off of a depth gauge for 2.0mm and 2.4mm screws during the reprocessing and cleaning of the instrument.There was no patient involvement and no procedure.This complaint involves one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed on the returned device (depth gauge for 2.0mm and 2.4mm screws, part # 319.006, 6702113).This complaint is confirmed.The part was reported to have a broken tip/needle, and it is confirmed since the photo provided shows the device was received at monument in multiple pieces.The hooked needle stem of the device is broken off at the base of the black body.Because the device has not yet been received at customer quality, this investigation was performed using the provided picture.The exact cause of the complaint condition cannot be determined.But the condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.Although the exact cause cannot be determined, the most probable root cause for this complaint is excessive force exerted on the depth gauge by placing / dropping heavy instruments on top of the device during the sterilization process.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.A visual inspection of the provided photo, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This particular depth gauge is part of at least 14 technique guides, including the 2.4 mm variable angle lcp distal radius system and is used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide.Top level assembly drawing and needle component drawing for the device were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The material of the needle component is an appropriate material for an instrument component of this type.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Relevance to complaint condition cannot be determined until the product is returned for investigation.Part 319.006 lot #6702113 contained non-conformance report (ncr) for an undersized major diameter of the thread feature on the needle component.As the complaint description notes the gauge is bent and most likely on the verge of breaking, the location of the bent was not reported.The review of the device history records(s) showed that there are potential issues during manufacture of the product what would contribute to this complaint condition.Upon further investigation at cq, and per product development subject matter expert (sme), "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." therefore, this ncr is not related 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 MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6175244
• MDR Text Key: 62462074
• Report Number: 1719045-2016-10913
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)6702113
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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: 6702113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2011
• 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