MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SCRRACK F/VC NO. 683.017 W/O CONT; TRAY, SURGICAL INSTRUMENT

Catalog Number 683.018

Device Problem Incorrect Measurement (1383)

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.Reporter is a synthes employee.Device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(6) reports an event as follows: it was reported that on an unknown date that the screw container does not correctly measure the length of the screws.The code 04.226.022, l22 / 4mm was tested and it read as l20 and one l40, it is l38.The problem was discovered in the imationty tank when we made the screw replacement because we noticed that our brace was poorly ordered.The measurements reflected in the secondary packaging did not correspond to the real one.This report is for one crack f/vc no.683.017 w/o cont.This is report 1 of 1 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.H3, h6: part: 683.018 (sub-component of 683.017), lot: 1040306, manufacturing site: oberdorf, release to warehouse date: august 26, 1999.The lot number search has shown that the lid with part number 683.018 was shipped as sub-component of the vario case 683.017 in the year 1999.The device history record (dhr) is not available as device is older than 20 years.The received pictures were reviewed and based only on the pictures, it is not possible to confirm this complaint as it is unknown which part numbers and length the shown screws have, therefore this complaint is rated a n/a in the confirmed field.Also it is not clear why the original markings of 202.608-202.650 and 202.714-202.749 were replaced with a sticker that shows different part numbers 04.226.010-04.226.040 and 04.226.116-04.226.140.These screws have a different head types which will have an influence on the measurement.Product was not returned, therefore no further investigation is possible.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.

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.The received pictures were reviewed and only based on the pictures it is not possible to confirm this complaint as it is unknown which part numbers and length the shown screws have, therefore this complaint is rated a n/a in the confirmed field.Also it is not clear why the original markings of 202.608-202.650 and 202.714-202.749 were replaced with a sticker that shows different part numbers 04.226.010-04.226.040 and 04.226.116-04.226.140.These screws have a different head types which will have an influence on the measurement.Product was not returned, therefore no further investigation is possible.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 history lot part: 683.018 (sub-component of 683.017), lot: 1040306, manufacturing site: oberdorf, release to warehouse date: aug.26, 1999.The lot number search has shown that the lid with part number 683.018 was shipped as sub-component of the vario case 683.017 in the year 1999.The dhr is not available as device is older than 20 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to se_075477 (filing and archiving of specification documents) version ai, which was in place till august 2014.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

Product complaint (b)(4).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.H11: d10: complainant was not returned; customer quality will conduct investigation based on the images provided.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: SCRRACK F/VC NO. 683.017 W/O CONT
• Type of Device: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9623489
• MDR Text Key: 191838869
• Report Number: 8030965-2020-00584
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 07611819093355
• UDI-Public: (01)07611819093355
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 683.018
• Device Lot Number: 1040306
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1