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

Catalog Number 319.010

Device Problem Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device is not distributed in the united states but is similar to device marketed in the usa.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent revision surgery because olecranon tension band wiring had been displaced.During the surgery, the surgeon could not measure with the depth gauge because it didn¿t slide well.He saturated the gauge with saline and applied glycerin, but the problem not improved.He used another depth gauge.The surgery was delayed by less than 30 minutes.The patient outcome was unknown.This is report 01 of 01 of (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part number: 319.010, lot number: 5l46877, manufacturing site: bettlach, release to warehouse date: 18.July 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the inspection of the depth gauge has shown that the surface at the outer diameter of the slider is strongly damaged in the area of the sleeve cut in, see attached pictures.Also we found that the one corner of the sleeve is slightly bend inward at the cut in.In general is the device is a used condition, there are wear marks all over, the tip of the feeler is slightly bend in different directions.Functional inspection: the device is functional, the slider can be moved forward and backward, but it is rough running, there is abnormal resistance present.The depth gauge can be assembled and disassembled as required, in this relation no deviation could be detected.Dimensional inspection: checked dimensions per drawing: inner sleeve diameter in general = pass, inner sleeve diameter next to the cut in = deformed.Drawing specification review: drawing was reviewed to verify the relevant dimension of the sleeve.The additional review of the manufacturing documents has shown that this lot did pass a 100% function test (slider must not jam) after manufacturing.Investigation conclusion: the complained does not slide well can be confirmed.The evaluation has shown that this is caused by the strongly damaged surface at the slider.This damage did lead to strong stress marks at the counterpart surface in the sleeve.Finally the damaged surfaces are responsible for the rough running.The initial cause of all damages is the corner at the sleeve cut in, which is slightly bent inward.This deformed corner did lead to the damage at the slider.Based on the provided information we are not able to determine the exact cause of this deformation.We can only assume that this occurred post-manufacturing, for example during reprocessing, as the device did pass the function test after manufacturing and as the used condition indicates that the depth gauge was apparently used different times without any issue previously.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 2.7MM & SMALL SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9746339
• MDR Text Key: 191314388
• Report Number: 8030965-2020-01355
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819020733
• UDI-Public: (01)07611819020733
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.010
• Device Lot Number: 5L46877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 03/06/2020
• Patient Sequence Number: 1
• Treatment: DEPTH GAUGE F/SCR Ø2.7-4 MEAS-RANGE UP-T