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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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) 6385564 is a lot/batch controlled item.The manufacture date of this item is may 18, 2010.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Part 319.006, lot 6385564.Release to warehouse date: may 18, 2010.Manufactured by synthes (b)(4).Review of the device history records showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.A non-conformance report was generated for undersized subcomponents.An evaluation of the destructive test results revealed that the force required to pull the worst case needle component from the slider component was 31% greater than the maximum force exerted by a participant in the manual pull test.Based on an evaluation of this data, as well as the intended use of the devices, there are no safety or functional concerns with devices assembled with the out-of specification components.Relevance to complaint condition cannot be determined until the product is returned for investigation.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 the tip of a depth gauge for 2.0 mm and 2.4 mm screws broke off.The issue was identified when restocking equipment.No issues with the device prior to discovery.No case or patient involvement.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Service and repair evaluation has been completed.The customer reported the tip of the depth gauge broke off.The repair technician reported tip broken as the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.Product investigation has been completed for part # 319.006, lot# 6385564.A visual inspection based on photos, device history records review and drawing review were performed as part of this investigation.The complaint is confirmed.This particular depth gauge is part of at least 14 technique guides 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.The part was reported to have a broken tip/needle, and it is confirmed since the photo provided shows the device was received 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 (b)(4), this investigation was performed using the provided picture.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 thickness of the needle (1.25 mm) is driven by the fact that the needle must fit into a drilled hole of 1.5 mm, and the length (80 mm) is determined so the slider can measure screws up to 40 mm.The material of the needle component is 316leh (l=low carbon, e=extra h=hard) 316 stainless steel (ss)), which 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.An exact root cause could not be determined; a 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.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6215712
• MDR Text Key: 63655007
• Report Number: 2530088-2016-10355
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)6385564
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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: 6385564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2010
• 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