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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE ROD, FIXATION ,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE ROD, FIXATION ,INTRAMEDULLARY Back to Search Results
Model Number 04.037.059S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Event year reported as 2018, exact date of postoperative nail breakage is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is synthes sales consultant. A review of the device history records has been requested. 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. 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 a patient underwent a hardware removal on (b)(6) 2018. The devices removed were a trochanteric fixation nail advanced (tfna) nail, unknown helical blade, and two (2) unknown locking screws. It was stated that approximately 4 days prior to the event, the patient presented to the emergency room (er) with progressing lateral hip pain. X-rays revealed a broken tfna nail at the blade nail junction. The patient's original implant procedure was done on (b)(6) 2018 due to subtrochanteric fracture. The fracture was repaired using a synthes proximal femur plate and screws. Procedure and patient outcome are unknown. Concomitant devices reported: helical blade (part# unknown, lot# unknown, quantity 1); locking screws (part# unknown, lot# unknown, quantity 2). This report is for one (1) tfna nail. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Device history lot manufacturing location: (b)(4), manufacturing date: 02-jun-2017, expiration date: 30-apr-2027, part number: 04. 037. 059s, 10mm/130 deg ti cann tfna 380mm/left ¿ sterile, lot number: h377821 (sterile). This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Component parts reviewed: part number: 04. 037. 942. 2, lock prong 130 degree, tfna, bp55, lot number: l367699, lot quantity: (b)(4), purchased finished goods traveler met all inspection acceptance criteria. Part number: 04. 037. 912. 4, wave spring, shim ended, bp55, lot number: h249496, part number: 04. 037. 912. 3, tfna lock drive, bp58, lot number: h369493, part number:21127, timoagri16. 00, bp80, lot number: h210699, device history review: this lot met all dimensional, visual, sterility and packaging criteria at the time of release 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.
 
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Brand Name10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE
Type of DeviceROD, FIXATION ,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8188637
MDR Text Key131132832
Report Number2939274-2018-55517
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.059S
Device Catalogue Number04.037.059S
Device Lot NumberH377821
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/25/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
Treatment
SEE EVENT DESCRIPTION
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