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 Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part: 319.006, synthes lot 5176129: release to warehouse date: (b)(6) 2006.Made by (b)(6).Review of the device history records(s) 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 because that the depth gauge assemblies contained a needle component with a male thread feature and a slider component with a corresponding female thread feature.The major diameter of the thread feature on the needle component of this depth gauge was found to be significantly undersized, in some cases so much so that there was minimal to no thread engagement.Many of the depth gauges assemblies containing the out-of specification needles exhibited a noticeable toggle of the needle with in the slider.The data from both tests was reviewed and evaluated from the standpoint of the patient and user safety as well as product fusion.An evaluation of the destructive test results revealed that the force required to pull the worst case needle component from the slider component was (b)(4)% greater than the maximum force exerted by a participial in the manual pull test.Based on and evaluation of this data, as well as the intended use of the devices, there were no safety or functional concerns with devices assembled with the out-of- specification components.The relevance of the complaint condition cannot be determined until the product is returned for investigation.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 during an open reduction internal fixation (orif) procedure to repair at the right elbow, the probe of a depth gauge for 2.0mm and 2.4mm screws broke off while the surgeon was using the device.All pieces of the device were retrieved and no fragments were left inside the patient.No surgical delay was reported and the surgery was completed successfully.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: one depth gauge for 2.0mm and 2.4mm screws (part # 319.006, lot # 5176129) was returned for investigation.It was reported to have a broken tip/needle, and it is confirmed since the device was received in multiple pieces.The hooked needle stem of the device is broken off at the base of the black body (the broken stem is approx.75mm in length) and was returned.The slider is loose in the hollow body.The handle has various marks and scratches, and the laser marking on the shaft is clearly visible.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.There is a protection sleeve to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.There is a protection sleeve to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage.No new, unique, or different patient harms were identified as a result of this investigation.The calculated occurrence rate is acceptable with the applicable design and clinical risk management occurrence rate.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.This complaint is confirmed.Device 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: 6076270
• MDR Text Key: 59067368
• Report Number: 2530088-2016-10305
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• 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: 5176129
• Other Device ID Number: (01)10886982189943(10)5176129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2006
• 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
• Patient Age: 81 YR