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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 456.318S
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2020
Event Type  malfunction  
Manufacturer Narrative
Additional procode: hwc. Complainant part is not expected to be returned for manufacturer review/investigation. 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. Investigation summary. The implant(s) was not returned and instead the investigation will be done based on the supplied image(s). The image(s) was reviewed and the complaint condition could be confirmed as some material can be seen through the proximal hole of the nail. As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable. A definitive assignable root cause could not be determined based on the provided information. During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device history lot part # 456. 318s synthes lot # 7130123 supplier lot # na release to warehouse date: dec 17, 2012 expiration date: nov 30, 2021 manufactured by synthes monument no ncr's were generated during production. Device history 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
It was reported that on (b)(6) 2020, a trochanteric fixation nail advanced (tfna) nail was found to have a defect. There was a piece inside the hole in the nail. The nail was inside the patient when the issue was discovered. The surgeon took the nail out and realized the problem, then opened up a new implant. There was a surgical delay of twenty (20) minutes. The procedure was completed successfully. The patient was stable following procedure. This report is for one (1) 11mm/130 deg ti cann troch fixation nail 170mm-sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10837806
MDR Text Key216182349
Report Number2939274-2020-05150
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model Number456.318S
Device Catalogue Number456.318S
Device Lot Number7130123
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 Received10/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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