MAUDE Adverse Event Report: SYNTHES BETTLACH DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Catalog Number 319.010

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/31/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.Additional information was received on jun 14, regarding the potential part and lot numbers of seven depth gauges, (part number 319.010) which may have been involved in the reported event.These were received by the manufacturer on jul 1, 2016.Each of the devices has a different lot number.It is unknown which if any of these devices were involved in the reported event since it was reported that a large fragment humeral plate was implanted and this gauge is for smaller screws than would be used for the implant.For conservative purposes, these devices were reported.The reported lot number and associated udi numbers are as follows: lot number 2045, other number - (b)(4), lot number 2295677, other number - (b)(4), lot number 2044, other number - (b)(4), lot number 2019141, other number - (b)(4), lot number 2538225, other number - (b)(4), lot number 2050, other number - (b)(4), and lot number 2163112, other number - (b)(4).(b)(6).A device history record review was performed for all seven potential lots.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.All seven lots were manufactured in bettlach.The manufacturing dates by lot are as follows: lot number 2045, manufacturing date jul 18, 1997; lot number 2295677, manufacturing date sep 11, 2007; lot number 2044, manufacturing date jun 9, 1997; lot number 2019141, manufacturing date dec 12, 2001; lot number 2538225, manufacturing date oct 29, 2009; lot number 2050, manufacturing date mar 13, 1998; and lot number 2163112, manufacturing date nov 3, 2005.Due to system character limitations, the results of the product development investigation will be submitted in a follow-up medwatch report.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 europe reported an event in (b)(6) as follows: it was initially reported to synthes on (b)(6) 2016 that the depth gauge does not measure correctly.On (b)(6) 2016, additional information was received reporting that the event occurred during surgery on (b)(6) 2015.The surgeon had placed a large fragment plate on the patienthumerus when it was discovered that the depth gauge did not measure correctly resulting in using screws that were too short.Additional information was not available and this event was initially determined to be non-reportable.On (b)(6) 2016, it was further reported to the manufacturer that the event resulted in a 45 to 60 minute surgical delay.Based on this new information, the event was re-evaluated and determined to be reportable.On june 14, 2016, additional information was again provided to the manufacturer reporting the complained depth gauge may belong to a second part number.Based on this new information, a separate report was created to capture the second potential part number.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the seven potential subject devices.The investigation has shown that on each of the returned instruments a significant deformation of the measuring-hook is visible.Furthermore, some of them show marks of metal on metal friction indicating that the measuring-hook has been bent intentionally by applying mechanical force using a tool.The review of the production histories revealed that these depth gauges were manufactured between 1997 and 2009 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.A design review of the different depth gauges in scope of this investigation could show that the devices are designed including features to avoid mixing up of components of different depth gauge types during assembling.Consequently, mixing spare parts of different depth gauges causing wrong assembly can be excluded as a root cause.According to the information received it was discovered that the depth gauge instrument did not measure correctly during placement of a large fragment plate on a humerus.Unfortunately, it is not known which of the returned instruments was used in this surgery.The instruction for use indicates that the depth gauge to determine the screw length for a large fragment plate is depth gauge 319.100.All depth gauges returned for investigation showed deformation on the tip due to mechanical force.The bending of the measuring hook tip is not considered in the instruction for use and leads to inaccurate screw length determination.Therefore, this manually performed mechanical deformation of the measuring tip is considered as misuse.In addition, according to the depuy synthes "function control" and depuy synthes "important information" leaflet , the affected devices should not have passed visual inspection prior to use in the surgical theatre.Furthermore, it could be demonstrated, that there is no impact on the screw length determination when components of depth gauges with the same article number are mixed.And, it could be demonstrated that deformed measuring hooks lead to a deviation of the screw length determination towards an overestimated screw length, e.G.Indicating longer lengths.Root cause: based on the type and extent of damage incurred indicates that this complaint was caused by wrong handling.The bending of the measuring hook tip is not considered in the instruction for use and leads to inaccurate screw length determination.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 2.7MM & SMALL SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5791888
• MDR Text Key: 49492885
• Report Number: 9612488-2016-10293
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR