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

Catalog Number 319.006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture/release to warehouse date: jun 22, 2005.The review showed that there were potential issues during the manufacture of the product that would contribute to this complaint condition.Part 319.006 lot 5026652 contained a nonconformance report (ncr) for a thread feature on the needle component of both the 319.004 and 319.006 depth gauges which were found to be significantly undersized.Many of the depth gauge assemblies exhibited a noticeable ¿toggle¿ of the needle within the slider.Both a manual pull test and destructive testing were conducted and evaluated.Based on the evaluation of the data, as well as the intended use of the devices, there was no safety or functional concerns with the devices assembled with the out-of-specification components.The relevance of the nonconformance to the complaint condition will be determined when the product is returned for investigation.Per the synthes product development subject matter expert, "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." 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 middle portion of two depth gauges stick and don't slide smoothly.This issue was during routine inspection after sterile processing while putting the sets away.There was no reported patient or procedural involvement.This report is 1 of 2 for com-(b)(4).

Manufacturer Narrative

Device returned to manufacturer.Service history review:.No service history review can be performed as part number 319.006 with lot number(s) 5026652 is a lot/batch controlled item.The manufacture date of this item is 22-jun-2005.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Service and repair evaluation was performed: the customer reported the middle part of the depth gauge was sticking and did not slide smoothly.The repair technician reported the tip was bent.Bent is 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.The evaluation was confirmed.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.

Manufacturer Narrative

Additional narrative: two (2) depth gauges for 2.0mm and 2.4mm screws (part number 319.006 / lot numbers 5026652 and 6569968) were received with the complaint category of ¿device interaction: does not fit with other parts.The complaint condition is confirmed as each depth gage was received with the body component showing slight resistance against the calibrated slider component during use.However, this has not impaired the function of each device.The body components can still be moved through their full range of motion by hand without significant force.Additionally it was noted that the tip was bent on lot 5026652 and that the tip was loose on lot 6569968.A device history record (dhr) review, visual inspection, functional test, and drawing review were performed as part of this investigation.Review of the device history record(s) showed that there were potential issues during the manufacture of the product that would contribute to this complaint condition.Part 319.006 lot 5026652 and lot 6569968 contained non-conformance (nc) for a thread feature on the needle component of both the 319.004 and 319.006 depth gauges which were found to be significantly undersized.Many of the depth gauge assemblies exhibited a noticeable ¿toggle¿ of the needle within the slider.Upon inspection, this nc was determined to be relevant for lot 6569968 as the needle was noted to loose but it is not relevant to lot 5026652 as this needle was bent; not loose.Per the nc, both a manual pull test and destructive testing were conducted, reviewed, and evaluated.Based on the evaluation of the data, as well as the intended use of the devices, there were no safety or functional concerns with the devices assembled with the out-of-specification components.The devices were dispositioned ¿use as is¿ (uai) as the needle would still be retained and functional.Thus, these devices are consistent with the uai justification and the issue has already been addressed.These depth gauges are used for measuring 2.0mm and 2.4mm screws in various trauma (including veterinary) plating systems.Based on the received condition the complaint condition is confirmed, consistent with the reported condition, and can be replicated.Based on the date of manufacture the relevant drawings were reviewed.During the investigation no product design issues or unaddressed discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Although the exact cause cannot be determined, the most probable root cause of the resistance between components is wear from use and repeated sterilization cycles over the life of the device.The other noted conditions are likely the result of handling and the documented nc.The bent needle is the result of a bending force applied to the needle portion of each depth gauge that is beyond the plastic deformation limit of the material.There is a protection sleeve to protect the needle during transport and the body that slides on the measuring portion adds additional protection to the needle attachment point during use.However, given the unknown conditions at the time of the damage the root cause could not be definitively determined.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: 6266352
• MDR Text Key: 65378097
• Report Number: 2530088-2017-10019
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)5026652
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 5026652
• 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: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2005
• 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