MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXNEURO SCREW SELF-DRILLING 4MM; PLATE, BONE

Catalog Number 04.503.104.04S

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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, during an unknown procedure, three (3) screws were not able to be inserted.The procedure was completed with a ten (10) minute surgical delay.No further information is available.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity 1), unknown matris neuro plate (part # unknown, lot # unknown, quantity unknown).This report is for one (1) ti matrix neuro screw self-drilling 4mm.This is report 1 of 3 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.H10: additional narrative: h3, h4, h6: part 04.503.104.04s, lot 55p4571: manufacturing site: bettlach.Release to warehouse date: may 15, 2020.Expiry date: may 01, 2030.A manufacturing record evaluation was performed for the finished device 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.

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.H3, h6: investigation summary: according to the information received, it was reported that this was an unknown procedure performed on (b)(6) 2020.Total 12 screws were used.Among them, three screws were not able to be inserted at all.The procedure was completed with 10-minute surgical delay.The products were returned to zuchwil customer quality for evaluation.Customer quality then conducted visual inspection, dimensional check and document specification review of the returned devices.During the visual inspection it can be seen that all screw tips are broken off.The broken fragments were not returned.Furthermore, the screw recesses are in an undamaged condition.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.No other visual damage could be observed.Dimensional inspection could not be performed due to the damage incurred.However, the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.It should be noted that product failure is multifactorial.Based on the information currently available, microscopic examination of the returned product indicates that the implant could have being damaged during or subsequent to implantation.A manufacturing related issue can be excluded.Although no conclusion could be reach on the cause of the reported event, the surgical technique guide (dsem/cmf/0614/0016(3) contain the following caution: "be aware that implants are not as strong as native bone.Implants subjected to substantial loads may fail".As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance device history lot, part: 04.503.104.04s, lot: 55p4571, manufacturing site: bettlach, release to warehouse date: 15.05.2020, expiry date: 01.05 2030.A manufacturing record evaluation was performed for the finished device 04.503.104.04s, lot: 55p4571 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.

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, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Customer retaining the product.Based on the information available, it has been determined that no corrective and 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: 04.503.104.04s lot: 55p4571 manufacturing site: bettlach release to warehouse date: 05.15.2020 expiry date: 05.01 2030 a manufacturing record evaluation was performed for the finished device 04.503.104.04s, lot: 55p4571 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: TI MATRIXNEURO SCREW SELF-DRILLING 4MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10823957
• MDR Text Key: 221287006
• Report Number: 8030965-2020-08861
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819901643
• UDI-Public: (01)07611819901643
• Combination Product (y/n): N
• PMA/PMN Number: K123723
• 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: 10/13/2020

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: 04.503.104.04S
• Device Lot Number: 55P4571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 01/27/2021; 03/10/2021
• Supplement Dates FDA Received: 01/05/2021; 01/29/2021; 03/23/2021
• Patient Sequence Number: 1
• Treatment: MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C; MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C; MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C; UNK - PLATES: MATRIXNEURO; UNK - SCREWDRIVERS