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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM; SCREW, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 02.211.014S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).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) 2019, during an unknown procedure, the surgeon attempted to implant plate with screws but was unable to fix the screws into the plate.Surgeon then attempted to implant the plate with new screws and successfully performed the procedure.No further information was provided.This report is for one (1) 2.7 mm va locking screw slf-tpng with t8 stardrive recess 14 mm.This is report 2 of 2 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
Additional event information the surgeon has come back and saying he was unable to get the screws to lock into the plate and they wouldn¿t torque.He mentioned he¿s familiar with the va double drill guide and doesn¿t think he went beyond 15 degrees (off axis).
 
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.Investigation flow: device interaction visual inspection: va lockscr ø2.7 head 2.4 self-tap l14 ss (quantity: 2) were received at us cq.But the allegation was against only one device.Upon visual inspection at cq, it is observed that both the screws received intact.The screw with the allegation cannot be distinguished as there is no lot number.So, both the screws are being investigated under this pi.Functional test: functional inspection of the received devices was performed at cq.The received 14mm va locking screws were threaded into all holes of the va distal fibula plate.It was observed that screws were properly inserted into all holes and locked as intended except holes 1 and 3.Can the complaint be replicated with the returned devices? yes dimensional inspection (calipers: ca802): dimensional inspection of the received screws was performed at cq.Document/ specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? yes investigation conclusion: visual inspection, functional test, and document specification review of the received device was performed at cq.The complaint is being confirmed as as functional test confirmed that the screws are not locking into holes 1 and 3 as intended.While a definitive root cause cannot be determined it is possible that the screw holes of the plate might have encountered unintended stress during procedure or handling.But there is no problem found with the device.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 no mre was performed as the lot number is unknown.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
Concomitant devices reported: variable angle (va) locking screw (part# 02.211.014s, lot# unknown, quantity: 8 ); va-lcp lat dist fibula pl 2.7 le 5ho l10 (part # 02.118.405s, lot # h370352, quantity 1).
 
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.
 
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Brand Name
2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9623236
MDR Text Key190035078
Report Number8030965-2020-00575
Device Sequence Number1
Product Code HWC
UDI-Device Identifier07611819425132
UDI-Public(01)07611819425132
Combination Product (y/n)N
PMA/PMN Number
K103243
Number of Events Reported1
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 Received01/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02.211.014S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Date Manufacturer Received04/07/2020
Patient Sequence Number1
Treatment
VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 SS; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 SS; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 SS; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 SS; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 SS; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 SS; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 SS; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 SS; VA-LCP LAT DIST FIBULA PL 2.7 LE 5HO L10
Patient Outcome(s) Required Intervention;
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