Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH . 4.5MM TI MULTILOC SCREW . LENGTH 42MM-STERILE; ROD,FIXATION,INTRAMEDULLARY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH . 4.5MM TI MULTILOC SCREW . LENGTH 42MM-STERILE; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.019.042S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Malunion of Bone (4529); Physical Asymmetry (4573)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Product was not returned.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: 04.019.042s.Lot: 55p7289.Manufacturing site: (b)(4).Release to warehouse date: may 27, 2020.Expire date: may 01, 2030.A manufacturing record evaluation was performed for the finished device 04.019.042s lot: 55p7289 and no non-conformances were identified.(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 on an unknown date that the patient will undergo for a revision surgery due to weak bone quality, the reduction was not sufficient, or the anchoring mechanism of the nail was not worked properly on (b)(6) 2020.The surgeon will remove the multiloc implants and implant the artificial bone head.On (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for proximal humerus fracture.The surgeon used the multiloc implants in the surgery and the surgery was completed successfully.After the surgery within 1 week, on an unknown date, the fixation by the nail were lost and the bone head was varus.It was unknown if the revision surgery completed successfully and any consequences with the patient.Concomitant device reported: multiloc end cap f/multiloc hn/phn extend (product code: 04.019.005, lot number: 59p0303, qty :1).Multiloc screw ø4.5 l36 tan (product code: 04.019.036, lot number: 46p7709, quantity :1 ).Multiloc screw ø4.5 l42 tan (product code: 04.019.042, lot number: 55p7289, quantity :1).3ockscr ø3.5 self-tap l32 tan (product code: 412.112, lot number: 69p0822, quantity :1).Lockscr ø3.5 self-tap l36 tan (product code: 412.115, lot number: 67p7423, quantity :1 ).Lockscr ø4 l26 f/nails tan dblue (product code: 04.005.416, lot number: 6l93655, quantity :1).Lockscr ø4 l26 f/nails tan dblue (product code: 04.005.416, lot number: 7l27803, quantity :1).This complaint involves eight (8) devices.This report is for (1).4.5mm ti multiloc screw length 42mm-sterile.This report is 3 of 8 for (b)(4).
 
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.H10 additional narrative: 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
. 4.5MM TI MULTILOC SCREW . LENGTH 42MM-STERILE
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11073594
MDR Text Key224517287
Report Number8030965-2020-09965
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819430655
UDI-Public(01)07611819430655
Combination Product (y/n)N
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number04.019.042S
Device Lot Number55P7289
Was Device Available for Evaluation? No
Date Manufacturer Received02/09/2021
Patient Sequence Number1
Treatment
3OCKSCR Ø3.5 SELF-TAP L32 TAN; 3OCKSCR Ø3.5 SELF-TAP L32 TAN; LOCKSCR Ø3.5 SELF-TAP L36 TAN; LOCKSCR Ø3.5 SELF-TAP L36 TAN; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; MULTILOC END CAP F/MULTILOC HN/PHN EXTEN; MULTILOC END CAP F/MULTILOC HN/PHN EXTEN; MULTILOC SCREW Ø4.5 L36 TAN; MULTILOC SCREW Ø4.5 L36 TAN; MULTILOC SCREW Ø4.5 L42 TAN; PHN MULTILOC Ø9.5 IZQ CAN L160 TAN; PHN MULTILOC Ø9.5 IZQ CAN L160 TAN
Patient Outcome(s) Required Intervention;
Patient Age78 YR
-
-