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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT Back to Search Results
Catalog Number 441.903S
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a legal professional.Without a lot number the device history records review could not be completed.Product was not returned.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) 2019, a patient underwent a removal procedure due to the breakage of the philos proximal humerus plate 3.5, 5 holes.The plate was originally implanted on (b)(6) 2018.Concomitant devices: cortex screw self-tapping l36mm titanium alloy (part: 404.836, lot: unknown, quantity: 1); locking screw self-tapping l40mm titanium alloy (part: 413.040, lot: unknown, quantity: 2); screw l46mm titanium alloy (part: 413.046, lot: unknown, quantity: 1); screw l44mm titanium alloy (part: 413.044, lot: unknown, quantity: 1); locking screw self-tapping l48mm titanium alloy (part: 413.048, lot: unknown, quantity: 1); titanium locking screw self-tapping 36mm (part: 413.036, lot: unknown, quantity: 3); locking screw self-tapping l50mm titanium alloy (part: 413.050, lot: unknown, quantity: 2); titanium locking screw self-tapping 34mm (part: 413.034, lot: unknown, quantity: 1).This report is for a 3.5mm titanium (ti) locking compression plate (lcp)® proximal humerus plate.This is report 1 of 1 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.A review of the device history record.Device history lot: part: 441.903s, lot: l400289, manufacturing site: raron, release to warehouse date: 29.May 2017, expiry date: 01.May 2027.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate 19267 was reviewed and the used material was according to iso-5832-2 specification for implants for surgery.H3, h6: investigation summary the received picture confirm the issue as per event description; the complaint therefore has been determined to be confirmed.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.
 
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
3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8627731
MDR Text Key145637905
Report Number8030965-2019-64229
Device Sequence Number1
Product Code KTW
UDI-Device Identifier07611819797796
UDI-Public(01)07611819797796
Combination Product (y/n)N
PMA/PMN Number
K011815
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 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number441.903S
Device Lot NumberL400289
Was Device Available for Evaluation? No
Date Manufacturer Received07/09/2019
Patient Sequence Number1
Treatment
CORTSCR Ø3.5 SELF-TAP L36 TI; LOCKSCR Ø3.5 SELF-TAP L34 TAN; LOCKSCR Ø3.5 SELF-TAP L36 TAN; LOCKSCR Ø3.5 SELF-TAP L40 TAN; LOCKSCR Ø3.5 SELF-TAP L44 TAN; LOCKSCR Ø3.5 SELF-TAP L46 TAN; LOCKSCR Ø3.5 SELF-TAP L48 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN; CORTSCR Ø3.5 SELF-TAP L36 TI; LOCKSCR Ø3.5 SELF-TAP L34 TAN; LOCKSCR Ø3.5 SELF-TAP L36 TAN; LOCKSCR Ø3.5 SELF-TAP L40 TAN; LOCKSCR Ø3.5 SELF-TAP L44 TAN; LOCKSCR Ø3.5 SELF-TAP L46 TAN; LOCKSCR Ø3.5 SELF-TAP L48 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN
Patient Outcome(s) Required Intervention;
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