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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/RIGHT-STERILE; ROD,FIXATION,INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.258S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).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
It was reported that on (b)(6) 2019, the patient underwent revision of the trochanteric fixation nailing advanced (tfna) nail due to broken tfna at junction of helical blade insertion.Implants were originally implanted on (b)(6) 2019.All implanted devices were completely removed.Procedure outcome and patient status are unknown.Concomitant devices reported: tfna helical blade (part # 04.038.395s, lot # 11l3172, quantity # 1), locking screw (part # 04.005.528s, lot # h851627, quantity # 1), titanium locking screw (part # 04.005.530s, lot # 10l6853, quantity # 1).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.H6: code 3191 used to capture surgical intervention and medical device removal.H3, h4, h6: manufacturing location: monument.Manufacturing date: 19-jul-2019.Expiration date: 30-jun-2029.Part number: 04.037.258s, 12mm/130 deg ti cann tfna 380mm/right- sterile.Lot number: 12l2546 (sterile).Lot quantity: (b)(4) work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.Component part(s) reviewed: part number: 04.037.912.4, wave spring, shim ended.Lot number: h794551.Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree tfna.Lot number: 10l6941.Lot quantity: (b)(4).Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive.Lot number: h881975.Lot quantity: 150.Production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 21127, timoagri16.00.Lot number: h883534.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certificate of analysis supplied by metalwerks inc.Was reviewed and determined to be conforming.Lot summary report dated met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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.Visual inspection: visual inspection performed at customer quality (cq) identified the nail broke at the proximal hole.The break is jagged and oblique.Hence the complaint can be confirmed.Further observation shows that the there is suspected drill marks on anterior-lateral side of the head hole.Document/specification review: no design issues or discrepancies were identified.Dimension inspection: it was not performed due to the post manufacturing damage investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed 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.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.Updated data-a3.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/RIGHT-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 Key9512717
MDR Text Key182725748
Report Number2939274-2019-62747
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,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.037.258S
Device Lot Number12L2546
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/17/2019
Date Manufacturer Received01/28/2020
Patient Sequence Number1
Treatment
5.0MM TI LOCK SCRW W/T25 STDRV 38MM F/IM NAIL-STR; 5.0MM TI LOCK SCRW W/T25 STDRVE 40MM F/IM NAIL-STR; TFNA FENESTRATED HELICAL BLADE 95MM - STERILE
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight84
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