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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/30MM-STER ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/30MM-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 412.111S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code: ktt. 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 at the time of filing this report. The 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: 412. 111s, lot: 6l27226, manufacturing site: (b)(4), release to warehouse date: october 11, 2019, expiry date: october 01, 2029. A manufacturing record evaluation was performed for the finished device part: 412. 111s, lot: 6l27226, and no non-conformances related to malfunction were identified. The nonconformance referred within the dhr is a planned one, that was aimed to monitor specific activities to manage all work orders (wo)) which were in wip in (b)(4) site, during the cutover phase for the transition from old erp (sap p01) to the new erp (sap p02). 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) 2021, the patient underwent for an open reduction internal fixation surgery for fracture of distal end of left tibia. The surgery was completed successfully without any surgical delay. Since the implants in question are still in the patient's body, no investigation on the implants is required. No further information is available. This complaint involves eleven (11) devices. This report is for (1) 3. 5mm ti locking scr slf-tpng w/stardrive recess/30mm-ster. This report is 2 of 11 for (b)(4).
 
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Brand Name3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/30MM-STER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12119195
MDR Text Key269731762
Report Number8030965-2021-05518
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number412.111S
Device Lot Number6L27226
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 Received06/11/2021
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: 07/05/2021 Patient Sequence Number: 1
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