MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS; GAUGE,DEPTH

Catalog Number 319.700

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 europe reports an event in (b)(6) as follows: it was reported that during an unknown surgical procedure on an unknown date, two (2) depth gauges did not function properly.When surgeon used each of them with a guide wire to measure the depth of a screw hole, the devices each gave different measurements.A third device was used to check the measurement.One of the complained devices measured the same as the third device while the other measured differently.The measurements differed by about 5 millimeters.Surgeon suspected the difference is due to either wear or breakage of the device.Surgery was completed successfully with no delay and no adverse consequence to the patient.Patient status reported as stable.Concomitant devices: guide wire (part unknown, lot unknown, quantity 1), depth gauge (part unknown, lot unknown, quantity 1).This report is for one (1) depth gauge.This is report 2 of 2 for (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.Described product problem was forwarded to sustaining engineering for evaluation: direct measuring device 319.70 and 319.700 are of a different design and can only be used with the corresponding surgical technique and screw racks.Based on the registration of the devices 319.70 should only be available in us and canada.The reason why the surgeon had both devices available does not form part of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part returned investigation site: sustaining engineering zuchwil trauma/cmf eu selected flow 2: device interaction / functional visual investigation: the received direct measuring-device f/guidewires ø2+2.8 is intact.The anodized color has partially disappeared.The device has the appearance to have been subjected to wrong decontamination procedures.The measuring scales inscriptions in question are still visible.Investigation conclusion: direct measuring device 319.70 and 319.700 are of a different design and can only be used with the corresponding surgical technique and screw racks.Based on the registration of the devices 319.70 should only be available in us and canada.The reason why the surgeon had both devices available does not form part of this investigation.For more details, please see attached product development investigation.The root cause was identified during the performed pd evaluation and therefore the in the investigation flow listed remaining investigation steps, document/specification review and dimensional inspection are not required.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.H3, h4, h6:device history lot part number 319.700 lot number: a4jm246 date of manufacture: 04-30-1999 place of manufacture: brandywine plant.Part expiration date: n/a (non-sterile) device history batch null, device history review the device history record(s) showed that there were no non-conformances or issues during the manufacture of the product that would contribute to this complaint condition.Lot number provided for reporting.Manufacture location provided for reporting.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: CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7949517
• MDR Text Key: 123363708
• Report Number: 8030965-2018-57136
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819064850
• UDI-Public: (01)07611819064850
• 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,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.700
• Device Lot Number: A4JM246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1