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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.037.259S
Device Problem Break (1069)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A device history record review has been requested.(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 on (b)(6) 2018, patient underwent revision surgery due to a broken left trochanteric femoral nailing advanced (tfna) nail.The tfna was originally implanted on (b)(6) 2018.Beginning on (b)(6) 2018, the patient experienced pain.On (b)(6) 2018, patient fell as a result of the pain, and presented to the emergency room the following day.The broken nail was discovered via x-ray.One small fragment of the nail was left in the patient, but the remaining pieces were removed.Distal nail was removed with re-opening of distal femur and pushed out top of femur.Current patient status is unknown.Concomitant devices: tfna screw 95mm (part: 04.038.095s, lot: h406589, quantity: 1), 5.0mm titanium (ti) locking screw 48mm (part: 04.005.538, lot: unknown, quantity: 1).This report is for a titanium (ti) cannulated tfna nail.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.Device history records review was completed for part: 04.037.259s, lot: h187245.Manufacturing location: (b)(4), manufacturing date: sep 19, 2016, expiry date: aug 31, 2026.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.Product investigation was completed.Upon visual inspection, it was observed that the nail was broken at its proximal end at the oblique hole where the helical blade would articulate with the nail.The fracture is representative of nail fracture patterns observed during bench-top fatigue testing.The oblique hole exhibits excessive wear on the respective contact surfaces for the head element (inferior medial and superior lateral) but the fracture surface itself appears homogenous with no voids, dark spots, or other irregularities in the metal.The proximal outer diameter had some scuff marks exposing base metal characteristic of marks incurred from rubbing on bone.The is one small, shallow gouge approximately 1.5mm long on the proximal end possibly due to contact with a drill or reamer.The definitive root cause could not be determined with the provided complaint details.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The received condition was determined to agree with the complaint description and therefore the complaint is confirmed.Due to post-manufacturing deformation, dimensional inspection could not be conducted.During the document/specification review the relevant drawings, reflecting the current and manufactured revision, were reviewed.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The material was reviewed, and the hardness value was confirmed to meet the specification with no relevant non-conformance noted.The exact cause of the complaint condition cannot be determined as the handling and the usage of the device are unknown.However, the complaint condition aligns with the cause of failure demonstrated during bench-top fatigue testing and the breakage of the nail is consistent with the result of excessive force applied that is beyond the yield limit of the material.The proximal end of the femoral nail was found to be broken at its oblique hole; thus the complaint is confirmed.No new product design issues or manufacturing discrepancies were identified during this investigation.Based upon the investigation findings, no additional corrective and/or preventative 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.
 
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.Additional narrative: exact date of event is unknown; event reportedly occurred in 2018 with the patient experiencing pain as of (b)(6) 2018.Part of device remained in the patient after the procedure on (b)(6) 2018; device not considered explanted.Facility name.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
12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8106149
MDR Text Key128418977
Report Number2939274-2018-55108
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982097392
UDI-Public(01)10886982097392
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
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number04.037.259S
Device Catalogue Number04.037.259S
Device Lot NumberH187245
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Date Manufacturer Received05/09/2019
Patient Sequence Number1
Treatment
SEE EVENT DESCRIPTION.
Patient Outcome(s) Required Intervention;
Patient Age83 YR
Patient Weight57
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