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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.003.029
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Date 03/29/2018
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. Complainant part is not expected to be returned for manufacturer review/investigation. Additional 510k code: k040336. (b)(4) used for: the screw was found to be too long postoperatively on x-ray but did not penetrate. The surgeon took the patient back into surgery where the screw were backed out a small amount. Without a lot number, the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
T was reported that the patient was implanted with one (1) recon-nail and two (2) recon-screws during a hip surgery on (b)(6) 2018. It was noticed with the help of post-operative x-rays, that the recon screws seemed too long, so the surgeon brought the patient back to the surgery on (b)(6) 2018 to back the screws out a couple of turns. The surgery was completed successfully without any delay. The patient status was reported to be fine at the end of the procedure. This complaint involves two (2) devices. This report is 2 of 2 for (b)(4).
 
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Brand Name6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES ÖSTERREICH GMBH (PRODUKTION)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7452558
MDR Text Key106247905
Report Number2939274-2018-51871
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.003.029
Device Catalogue Number04.003.029
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 Received05/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/23/2018 Patient Sequence Number: 1
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