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

Catalog Number 319.01

Device Problems Display Difficult to Read (1181); Incorrect Measurement (1383); Misassembled (1398)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient identifier, date of birth/age, and weight are unknown.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the service history records has been requested and is currently pending completion.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 used during surgery on (b)(6) 2015 and gave off an inaccurate reading due to components of the depth gauge not fitting together properly.Two (2) screws were therefore read incorrectly and did not fit properly into the patient upon insertion.As a result, the surgeon had to remove those screws.They were replaced with other screws using another depth gauge.The procedure was successfully completed with a three to five minute delay.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis a service history record review was attempted but could not be completed because the subject device is a lot-controlled item.The manufacture date of this item is 14-dec-2012.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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: service & repair evaluation: the customer reported depth gauge was two different pieces so it did not measure correctly.The repair technician reported missing parts as the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit on september 28, 2015.Product investigation summary: one depth gauge for 2.7mm and small screws (part 319.01 / lot 8102210) and one depth gauge for 2.7mm and small screws (part 319.04 / lot unknown) were received with the complaint category of ¿does not/will not function: will not measure.¿ the complaint condition is confirmed.The received components are a mix of components from the two devices.Although the devices are each made up of four components (slider assembly, guide sleeve, knurled cap, and headpiece assembly), they are separate component numbers and dimensionally different, with the exception of the knurled cap.If used together, the components would give an inaccurate reading.While it cannot be definitively determined, the most probable cause of the complaint condition is the improper assembly of the device using components from different part numbers.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Service and repair history reviews and evaluations were performed for the returned depth gauge.No service history review could be performed as this is a lot controlled item.The manufacture date of the item was december 14, 2012.The source of the manufacture date is the release to warehouse date.The repair technician confirmed the condition and found the device to not be repairable.Further evaluation shows that these depth gauges are intended for use across various plating procedures for the measurement of 2.7mm to 4.0mm screws.The received components are a mix of components from the two devices.The returned depth gauges were received partially assembled with minor surface wear.One slider assembly from part number 319.04 was received.One guide sleeve and one headpiece assembly from part number 319.01 were received.One knurled cap was received, but, as the component number is the same for both assemblies, the device it came from could not be determined.The components that were received are intact and in working condition individually.However, if they were used together the components would give an inaccurate reading as reported.A review of the current design drawing for the top level assemblies was performed.The following component drawing were also reviewed; handpiece assemblies, handpieces, slider assemblies, guide sleeves, and knurled cap.During the investigation, no product design issues or 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.While it cannot be definitively determined, the most probable cause of the complaint condition is the improper assembly of the device using components from different part numbers.The error likely occurred during reassembly after disassembly for sterile processing.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 2.7MM & SMALL SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5022717
• MDR Text Key: 23832564
• Report Number: 3003875359-2015-10373
• 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
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.01
• Device Lot Number: 8102210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2012
• 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