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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.044S
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. 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. Device history lot: part # 04. 037. 044s, synthes lot # h581880, supplier lot # na, expiration date: march 1, 2028, release to warehouse date: march 12, 2018, manufactured by synthes (b)(4), no ncr's were generated during production. Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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) 2020 during an open reduction internal fixation (orif) procedure for left femoral trochanteric fracture, the surgeon inserted the nail for "right" and completed the surgery without any surgical delay. After the procedure, the nurse noted and the surgeon found that the nail for "right" was used for the patient's "left" trochanteric fracture. The surgeon is considering the response. The patient outcome was reported as stable. There is no further information available. This report is for one (1) 10mm/130 deg ti cann tfna 235mm/right - sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10919827
MDR Text Key218728952
Report Number8030965-2020-09247
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.044S
Device Lot NumberH581880
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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