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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.013.050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
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. (b)(4). Investigation summary: 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 number: 04. 013. 050, lot number: 6781134, part manufacturing date: 27 september 2011, manufacturing site: (b)(4), part expiration date: n/a, nonconformance noted: ncr # 1041955. A review of the device history record revealed no complaint related anomalies. The device history record shows lot 6781134 of ti spiral blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted. This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record(s) determined the raw material lot 6650254 was opened on ncr # 1041955. This nonconforming report was opened due to observed discoloration at the ends of some raw material bars. The nonconformance investigation determined that this condition had no negative impact on the material, as the ends of each bar are removed during processing without being incorporated into any parts. This nonconformance is determined not to have any relevance to the complaint condition. Device history review: a review of the device history record revealed no complaint related anomalies. This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that 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) 2019, the patient underwent a revision surgery due to chronic osteomyelitis, infection, inflammation, nonunion of joint, and delayed healing. One (1) hindfoot nail, one (1) spiral blade, one (1) 6mm unknown locking screw, and one (1) 5mm unknown locking screw were removed. All hardware was intact. After the removal, the extremity of the patient was i&d using ria. There was no surgical delay.   it is unknown if procedure was successfully completed. Patient status was good. This complaint involves four (4) devices. This is 4 of 4 for report (b)(4).
 
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Brand NameTI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX
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)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9342485
MDR Text Key185708018
Report Number2939274-2019-62278
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033618
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.013.050
Device Catalogue Number04.013.050
Device Lot Number6781134
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 Received11/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2011
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: 11/19/2019 Patient Sequence Number: 1
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