MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 03.815.029

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 at the time of filing this report.A review of the device history records has been requested.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a in- house product demonstration: alif presentation in the office demonstrating the squid, while practicing putting it together the following was observed: the 03.815.030 (silver rail with green handle) would slide over the 03.815.029 evol squid assemb/disassemb tool (black three piece) however this would remove slices of the black rail and make a carving noise while sliding the inserter over it.This report is for two (2) device.This report is 1 of 2 for (b)(4).

Event Description

This report is 1 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.A device history record (dhr) review was conducted: part: 03.815.029 lot: l244731 manufacturing site: hägendorf release to warehouse date: 19.Jan.2017 the device history record shows this lot of 11 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Yes, the received condition agrees with the complaint description.Yes, the complaint can be replicated with the returned device.No, a design defect or deficiency did not contribute to the complaint condition.Received condition of device: customer returned 4 parts.Evolsquid synthes quick insert+distract art.No.: 03.815.030: both returned instruments are in a sound condition and show normal signs of usage.Evolsquid assemb / disassemb tool art.No.: 03.815.029: the two ppsu tools are as the other two instruments in a sound condition.On the surfaces where the inserter and distractor instrument glides, are grinding marks visible.The returned instruments show visible traces of wear which could potentially be the cause of the observed slices on the a-d tool.According to our important information ifu (se_023827) damaged and excessively worn devices should not be used anymore.Therefore, it can be stated that the black ppsu slices would not be pushed into the wound with the cage.The incorrect date was inadvertently utilized in initial medwatch.The correct date is october 17, 2018.  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: EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8107552
• MDR Text Key: 128561106
• Report Number: 8030965-2018-58496
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819534513
• UDI-Public: (01)07611819534513
• 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,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.815.029
• Device Lot Number: L244731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 12/04/2018; 11/22/2018; 01/16/2019
• Supplement Dates FDA Received: 12/12/2018; 12/13/2018; 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1