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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CRANIAL-SCR PLUSDRIVE 1.6 SELF-DRILL L3; SCREW,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH CRANIAL-SCR PLUSDRIVE 1.6 SELF-DRILL L3; SCREW,FIXATION,BONE Back to Search Results
Catalog Number 400.833S
Device Problem Difficult to Advance (2920)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 08/04/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Device is not distributed in the united states, but is similar to device marketed in the usa.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.(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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the proper insertion of 3mm screws was not possible.The screws were rejected and 4mm screws were used instead.Concomitant device: unk - screws: trauma (part# unknown, lot# unknown, quantity unknown).This report is for one (1) cranial-scr plusdrive ø1.6 self-drill l3.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.D4: lot number reported as either 31p3731, 56p8617, or 61p1045.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.Investigation summary part: 400.833s, lot: 31p3731, manufacturing site: bettlach, release to warehouse date: 17 december 2019 , expiry date: 01 december 2029.Part: 400.833s, lot: 56p8617, manufacturing site: bettlach, release to warehouse date: 03 june 2020 , expiry date:01 may 2030.Part: 400.833s, lot: 61p1045, manufacturing site: bettlach, release to warehouse date: 07 july 2020 , expiry date: 01 june 2030.A manufacturing record evaluation was performed for the above listed finished devices 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.
 
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Brand Name
CRANIAL-SCR PLUSDRIVE 1.6 SELF-DRILL L3
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10382041
MDR Text Key209199508
Report Number8030965-2020-05767
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
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 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number400.833S
Was Device Available for Evaluation? No
Date Manufacturer Received10/28/2020
Patient Sequence Number1
Treatment
UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
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