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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 TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.145S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Product was not returned.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 history lot: manufacturing location: (b)(4), manufacturing date: 08-nov-2017, expiration date: 30-sep-2027, part number: 04.037.145s, 11mm/130 deg ti cann tfna 235mm/left- sterile, lot number: h491563 (sterile).Component part(s) reviewed: part number: 04.037.942.2, lock prong, 130 degree, tfna, bp55, lot number: l585977, part number: 04.037.912.4, wave spring, shim ended, bp5, lot number: h316274, part number: 04.037.912.3, tfna lock drive, bp58, lot number: h480007, part number: 21127, timoagri16.00, bp80, lot number: h282099.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.(b)(4).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 the patient will undergo a removal surgery due to a broken titanium cannulated proximal femoral nailing system (tfna) on (b)(6) 2020.The surgeon stated that the patient ¿plopped¿ down in a chair and broke the nail at the lag screw hole on an unknown date.No further information provided.Concomitant devices reported: unknown tfna lag screw (part# unknown, lot# unknown, quantity 1), unknown locking screw (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) 11mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d7: explanation date updated.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
Updated concomitant device: tfna fenestrated screw (part 04.038.195, lot 32p4633, quantity 1).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the device was broken into multiple fragments through the holes of the helical blade and locking screw.The broken fragments were returned.Drill marks were observed on the walls of the helical blade.There were scratches on the device due to implantation and explanation of the device but have no impact on the device functionality.No other issues were identified with the returned device.The outer diameter of the tfna nail was measured within the specification.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition is confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Due to the received condition, it could not be determined during investigation whether the drill marks caused or contributed to the break.Relevant actions have been taken to address the issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 Name
11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key10750643
MDR Text Key213693989
Report Number2939274-2020-04857
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982096579
UDI-Public(01)10886982096579
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,health
Type of Report Initial,Followup,Followup,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number04.037.145S
Device Catalogue Number04.037.145S
Device Lot NumberH491563
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/28/2020
Supplement Dates Manufacturer Received11/02/2020
11/09/2020
11/24/2020
Supplement Dates FDA Received11/05/2020
11/24/2020
11/25/2020
Patient Sequence Number1
Treatment
TFNA FENESTRATED SCREW 95MM; UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - SCREWS: LOCKING
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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