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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø5 SELF-TAP L28 TAN; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

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SYNTHES GMBH LOCKSCR Ø5 SELF-TAP L28 TAN; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE Back to Search Results
Catalog Number 413.328S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Type  Injury  
Event Description
Device report from depuy synthes reports an event in japan as follows: this is report 4 of 6 for (b)(4).It was reported by the sales rep in japan that on (b)(6) 2021, the patient underwent the open reduction internal fixation with the dhs for the fracture of the right femoral neck.The surgery was completed successfully without any surgical delay.On (b)(6) 2022, the postoperative x-rays showed that crushing of the femoral head and protrusion of the 6.5 ccs into the hip joint.On (b)(6) 2022, this event was found during a meeting with another physician than the one in charge of the case.The sales rep has not been able to meet with the surgeon.According to another physician, it seemed to be osteonecrosis of the femoral head.There was no clear description in the medical record regarding osteonecrosis of the femoral head.The revision surgery with removal of the implants and the bipolar hip arthroplasty was schedule to be performed on (b)(6) 2022.No further information is available.This complaint involves six(6) devices.
 
Manufacturer Narrative
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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: 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 review: a manufacturing record evaluation was performed for part: 413.328s, lot: 9234835; and no non-conformances were identified.
 
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Brand Name
LOCKSCR Ø5 SELF-TAP L28 TAN
Type of Device
ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ   2544
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14757342
MDR Text Key294936123
Report Number8030965-2022-04196
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K000682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number413.328S
Device Lot Number9234835
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/25/2022
Initial Date FDA Received06/21/2022
Supplement Dates Manufacturer Received06/30/2022
Supplement Dates FDA Received07/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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