MAUDE Adverse Event Report: SYNTHES BETTLACH DEPTH GAUGE FOR LARGE SCREWS; GAUGE, DEPTH

Catalog Number 319.100

Device Problem Incorrect Measurement (1383)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Manufacturing location: (b)(4).Manufacturing date: may 13, 2015.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that there were concerns with the readings on the gauge at extremity of the gauge.The measurement of the extremity of the gauge reads 20mm while the gauge provides a 25mm length.The instrument and its calibration was tested by the facility and the measures were found to be incorrect.The product was tested by a medical equipment company technician/representative and seems to be conforming.In total were (b)(4) instruments with the same lot were affected.This is report 2 of 2 for com-(b)(4).

Manufacturer Narrative

Device available for evaluation? the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Corrected data: it was reported there was no patient involvement, relevant tests/lab data, other relevant history, patient code.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 this event did not occur during a procedure.

Manufacturer Narrative

Product investigation summary: two (2) depth gauges for large screws (part: 319.100 / lot: 9433002) were received for evaluation.The devices were received in the original cardboard boxes with no visible signs of wear and tear on the surface of either device.The movable parts are working as per design intended.The manufacturing review has shown that the production procedure was according to specifications and that there were no issues that would have contributed to this complaint condition.The relevant dimensions were measured with a standard measuring-rod and found to be according to the drawing¿s specifications.The articles in question were produced in a quantity of (b)(4) pieces in may, 2015.The manufacturer is not aware of any quality problems or failures caused by a faulty product with this article¿s part number.Based on the investigation results, and the received information, an exact root cause cannot be determined.The sliding mechanism was tested by the investigators and found to function as intended.To ensure a correct measurement with the depth gauges, the user is instructed to use the corresponding plate, as the scale on the depth gauges includes the screw head length.Therefore, a correct reading of the length would be guaranteed.No product fault could be detected.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 LARGE 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: 5701186
• MDR Text Key: 46640998
• Report Number: 9612488-2016-10263
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.100
• Device Lot Number: 9433002
• Other Device ID Number: (01)07611819020795(10)9433002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• 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