MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL SPACER APPLICATOR KNOB; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.004

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.The investigation could not be completed; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2019, assembling of two (2) applicator knob and applicator outer shaft were difficult, the parts are jamming and it's hard to disassemble the instruments.It is unknown how was the issue discovered.There was no procedure and patient involvement.This complaint involves four (4) devices.This report is for one (1) t-pal spacer applicator knob.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.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

Updated event description: device report from synthes reports an event in germany as follows: it was reported that assembling of two (2) applicator knob and applicator outer shaft were difficult, the knob cannot be removed from the outer shaft, the parts are jamming and it's hard to disassemble the instruments.The knob was very stiff and could not be separated after countless back and forth turning.The inner shaft could be fix well.It was during training with the instruments when the allegation was determined.There was no procedure and patient involvement.

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.H10 additional narrative: h3, h4, h6: all three components, the applicator outer shaft, the applicator inner shaft and the applicator knob are jammed together.The release button of the applicator knob is blocked.A functional test cannot be carried out as the devices are jammed together and cannot be separated.A dimensional inspection cannot be carried out as the devices are jammed together and cannot be separated.Conclusion: the complaint is confirmed for damage codes "unable to disassemble" and "jammed/seized".Even if the applicator knob on the applicator outer shaft is jammed, it can be turned back and forth a little bit.The audible frictional noise indicates a lack of lubrication.Although we are not able to determine the exact root cause of the damage, we suspect that the instrument was not lubricated.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.Device history lot: part: 03.812.004.Lot: l938266.Manufacturing site: hägendorf.Release to warehouse date: 18.Sept.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: T-PAL SPACER APPLICATOR KNOB
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8438693
• MDR Text Key: 139426201
• Report Number: 8030965-2019-62115
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819414624
• UDI-Public: (01)07611819414624
• Combination Product (y/n): N
• PMA/PMN Number: K151276
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.004
• Device Lot Number: L938266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1