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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; BONE PLATE
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OBERDORF SYNTHES PRODUKTIONS GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; BONE PLATE Back to Search Results
Catalog Number 400.834S
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
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 reports an event in (b)(6) as follows: it was reported that during excision of glioma of the brain on (b)(6) 2019, the body of the three (3) cranial screws were deformed when screwed to a non-j&j plate, while another three (3) cranial screws broke off.Thus, another device was used to complete the surgery.There was no surgical delay and no adverse consequences reported to the patient.Concomitant device reported: unknown non-j&j plate (part # unknown, lot # unknown, quantity unknown).This is report 2 of 6 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.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.The cranial screw was received at the us cq.The tip of the screw¿s shaft was bent, notably curved to one side.No other issues could be identified with the returned portions of the device.A dimensional inspection was not performed due to post-manufacturing damage.The received device was manufactured at the monument site on 28 january 2018.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The complaint was confirmed for the cranial screw.The tip of the screw was curved over to the side.There was no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it was possible that the device encountered unintended forces.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot, part: 400.834s, lot: l809124, manufacturing site: bettlach, release to warehouse date:13.March 2018, expiry date: 01.March 2028.A manufacturing record evaluation was performed for the sterile finished device lot number, and no non-conformances were identified.The complained screw in the sterile set was manufactured in synthes us: part: 400.834.05, lot: h556025.Manufacturing location: monument, manufacturing date: 28-jan-2018, part number: 400.834, ti low profile neuro screw self-drilling 4mm, lot number: h556025 (non-sterile).Component part(s) reviewed: 21015, tialnbri4.00, lot number: h288739, this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.
 
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Brand Name
TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
Type of Device
BONE PLATE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8684075
MDR Text Key147513905
Report Number8030965-2019-65150
Device Sequence Number1
Product Code JEY
UDI-Device Identifier07611819771468
UDI-Public(01)07611819771468
Combination Product (y/n)N
PMA/PMN Number
K022012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number400.834S
Device Lot NumberL809124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2019
Date Manufacturer Received07/18/2019
Patient Sequence Number1
Treatment
UNKNOWN NON-J&J PLATE; UNKNOWN NON-J&J PLATE
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