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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED VA LOCKING SCREW/85MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED VA LOCKING SCREW/85MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE Back to Search Results
Model Number 02.205.085
Device Problem Break (1069)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Unknown date.Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.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 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 surgery due to a one (1) variable angle-locking compression plate (va-lcp) curved condylar plate and one (1) 5.0 mm cannulated locking screw 85 mm were broken and nonunion of the left femur.The plate broke at the junction of the second combi hole.An 85 mm 5.0 cannulated locking screw as broke at the screw head.The other cannulated locking screws and cortex screws were removed but not broken.It was revised with another plate.Initial date of the surgery was on (b)(6) 2019.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Concomitant device reported: 5.0 mm cannulated locking screws 85 mm (part # 02.205.085, lot # unknown, quantity 2) 5.0 mm cannulated locking screws 80 mm (part # 02.205.080, lot # unknown, quantity 2), 5.0 mm cannulated locking screw 35 mm (part # 02.205.035, lot # unknown, quantity 1), 4.5 mm cortex screw self-tapping 36 mm (part # 214.836, lot # unknown, quantity 3), 4.5 mm cortex screw self-tapping 44 mm (part # 214.844, lot # unknown, quantity 2), 4.5 mm cortex screw self-tapping 46 mm (part # 214.846, lot # unknown, quantity 1), 4.5 mm cortex screw self-tapping 42 mm (part # 214.842, lot # unknown, quantity 1).This report is for one (1) 5.0 mm cannulated locking screw 85 mm this is report 2 of 2 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.A review of the device history record device history lot , part: 02.231.685, lot: 2l13399, manufacturing site: mezzovico, release to warehouse date: 31.Oct.2018.Investigation summary background: updated event description: it was reported that on (b)(6) 2019, the patient underwent revision surgery due to a one (1) variable angle-locking compression plate (va-lcp) curved condylar plate and one (1) 5.0mm cannulated locking screw 85mm were broken and nonunion of the left femur.The plate broke at the junction of the second combi hole.An 85mm 5.0 cannulated locking screw as broke at the screw head.The other cannulated locking screws and cortex screws were removed but not broken.It was revised with another plate.Initial date of the surgery was on january 17, 2019.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Concomitant device reported: 5.0mm cannulated locking screws 85mm (part # 02.205.085, lot # unknown, quantity 2) 5.0mm cannulated locking screws 80mm (part # 02.205.080, lot # unknown, quantity 2), 5.0mm cannulated locking screw 35mm (part # 02.205.035, lot # unknown, quantity 1), 4.5mm cortex screw self-tapping 36mm (part # 214.836, lot # unknown, quantity 3), 4.5mm cortex screw self-tapping 44mm (part # 214.844, lot # unknown, quantity 2), 4.5mm cortex screw self-tapping 46mm (part # 214.846, lot # unknown, quantity 1), 4.5mm cortex screw self-tapping 42mm (part # 214.842, lot # unknown, quantity 1) this complaint involves two (2) devices.Investigation flow: damage visual inspection: the 5.0 mm cannulated va locking screw, 3.5 mm hex (p/n 02.231.685 lot 2l13399) was received in two pieces.The screw head was completely broken off from the threaded shaft.No other issues were identified with the returned components of the device.The following screw implants were returned as a concomitant device without an alleged complaint condition.P/n: 02.231.685 lot 2l13399 , p/n: 02.231.680 lots 2l02866, l825287, l631086 , p/n: 02.231.635 lot 9440760, p/n: 214.8xx (4.5 mm cortex screws, hex) lots unk qty: 7.Upon visual inspection, there is no evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed on these devices.Dimensional inspection: drawing: 5.0 cannulated va locking screw se-373515 rev g , feature: threaded screw shaft major diameter.Document/specification review: the following drawing, reflecting the current and manufactured revision, was reviewed.5.0 cannulated va locking screw se_373515 rev g, during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the 5.0 mm cannulated va locking screw, 3.5 mm hex (p/n 02.231.685 lot 2l13399) as the screw head was completely broken off from the threaded shaft.While no definitive root cause could be determined, it is possible that condition was due to early excessive strain by patient or the screws incorrectly locked to plate (not properly torqued).During this investigation no product design or manufacturing issues 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Lot number provided for reporting.Manufacture site provided for reporting.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.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.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
Concomitant device reported: 5.0mm cannulated variable angle locking screw 85mm (part # 02.231.685, lot # 2l13399, quantity 1), 5.0mm cannulated variable angle locking screw 80mm (part # 02.231.680, lot # 2l02866, quantity 1), 5.0mm cannulated variable angle locking screw 80mm (part # 02.231.680, lot # l825287, quantity 1), 5.0mm cannulated variable angle locking screw 80mm (part # 02.231.680, lot # l630086, quantity 1), 5.0mm cannulated variable angle locking screw 35mm (part # 02.231.635, lot # 9440760, quantity 1), 4.5mm cortex screws (part # 214.8xx, lot # unknown, quantity 7).
 
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Brand Name
5.0MM CANNULATED VA LOCKING SCREW/85MM
Type of Device
IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8670768
MDR Text Key147062112
Report Number2939274-2019-58480
Device Sequence Number1
Product Code JDP
UDI-Device Identifier10886982049797
UDI-Public(01)10886982049797
Combination Product (y/n)N
PMA/PMN Number
K110354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup,Followup
Report Date 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number02.205.085
Device Catalogue Number02.231.685
Device Lot Number2L13399
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Date Manufacturer Received07/03/2019
Patient Sequence Number1
Treatment
4.5MM CORTEX SCREW SELF-TAPPING 36MM; 4.5MM CORTEX SCREW SELF-TAPPING 42MM; 4.5MM CORTEX SCREW SELF-TAPPING 44MM; 4.5MM CORTEX SCREW SELF-TAPPING 46MM; 5.0MM CANNULATED LOCKING SCREW 35MM; 5.0MM CANNULATED LOCKING SCREW 80MM; 5.0MM CANNULATED LOCKING SCREW 85MM; 5.0MM CANNULATED VA LOCKING SCREW/35MM; 5.0MM CANNULATED VA LOCKING SCREW/80MM; 5.0MM CANNULATED VA LOCKING SCREW/85MM; UNK - SCREWS: CORTEX; 4.5 MM CORTEX SCREW SELF-TAPPING 36 MM; 4.5 MM CORTEX SCREW SELF-TAPPING 42 MM; 4.5 MM CORTEX SCREW SELF-TAPPING 44 MM; 4.5 MM CORTEX SCREW SELF-TAPPING 46 MM; 5.0 MM CANNULATED LOCKING SCREW 35 MM; 5.0 MM CANNULATED LOCKING SCREW 80 MM; 5.0 MM CANNULATED LOCKING SCREW 85 MM
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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