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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: TIBIAL ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAILS: TIBIAL ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - nails: tibial/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j representative. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient had an infection who got protect tibial nail on a primary open fracture. Concomitant device reported: unk - screws: (part# unknown; lot# unknown; quantity: unknown). This complaint involves one (1) device. This report is for (1)unk - nails: tibial. This report is 1 of 3 for (b)(4).
 
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Brand NameUNK - NAILS: TIBIAL
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key12568017
MDR Text Key274453971
Report Number8030965-2021-08310
Device Sequence Number1
Product Code HSB
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
Report Date 09/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
Treatment
UNK - SCREWS: TRAUMA
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