MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE, DEPTH

Catalog Number 319.004

Device Problem Incorrect Measurement (1383)

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

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.Service history record review: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is may 21, 2002.The source of the manufacture date is the release to warehouse date.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.

Event Description

It was reported that a depth gauge was reading incorrectly during an open reduction internal fixation (orif) procedure of the fifth metatarsal.The depth gauge was reading 2mm too long.The surgeon measured for a screw length of 13mm with the depth gauge, but the properly fitted screw was an 11mm screw.This issue also occurred on two (2) other screw measurements during the surgery.As a result, there was a five (5) to ten (10) minute surgical delay.The procedure was completed successfully with no reported patient harm.No additional information was available.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair evaluation was performed for the subject device.The customer reported the depth gauge was reading 2mm too long.The repair technician reported the item was not reading correctly.¿worn-out parts¿ is the reason for repair.The item is not repairable.The cause of the issue is unknown.The item was forwarded to the synthes complaint handling unit (chu) for additional investigation and was received at the chu on (b)(4) 2015.The service and repair evaluation was confirmed.The results of the additional investigation are pending.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product investigation summary: one depth gauge for 1.3mm and 1.5mm screws (part 319.004 / lot 4422286) was received.The complaint condition is confirmed as the depth gauge was received with the dimension from the ¿0¿ graduation to the needle hook flat face measuring approximately 1mm short of the minimum specification.This would result in the depth gauge reading being too long and thus suggesting a longer screw than needed.Based on the received condition, it is most probable that the complaint is the result of a manufacturing issue.The evaluation found that the depth gauge is intended for use in measuring for 1.3 and 1.5mm screws in various plating systems and is listed in techniques guides for headless compression screws, the modular hand system, and the rotation correction plate system.The depth gauge was received intact with all components.The device shows surface scratches and worn edges consistent with the expected result from extensive use over the devices approximately 13.5 year lifespan.There is tape on the handle, presumably placed by the user.The dimension from the ¿0¿graduation to the needle hook flat face measures approximately 83mm compared to the specified inspection value of 84.8mm +/- 0.8 per drawing.The needle shows a slight bend, but not enough to impact the measurement by 1mm.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.A review of the current design drawing / manufactured revision for the top level assembly and the needle component was performed.During the investigation, no product design issues were observed.However, a discrepancy in the needle length, as described above, was noted as the dimension from the ¿0¿graduation to the needle hook flat face measures approximately 1mm short of the minimum specification.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.

Manufacturer Narrative

A manufacturing evaluation was completed: device was received with all components intact with surface scratches indicative of normal usage and wear.Feature l1 for component part 319.004.05 was found to be conforming along with the raw material.Feature l1 for top level part 319.004 was found to be undersize by approximately 2mm.Raw material for component part 319.004.3 was unobtainable due to not enough surface area for niton to read the material type.Functional test was not performed due to it not being applicable to complaint condition and being used to test the device's sliding function.Complaint has been confirmed from a manufacturing (assembly) perspective.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 1.3MM AND 1.5MM 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5258438
• MDR Text Key: 32579099
• Report Number: 1719045-2015-10782
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.004
• Device Lot Number: 4422286
• Other Device ID Number: (01)10886982189936(10)4422286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2002
• 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: 22 YR