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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW, FIXATION, BONE Back to Search Results
Device Problems Break (1069); Unintended Movement (3026)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Event date: unknown when 4.5mm cortex screw broke and nonunion began.510k: this report is for an unknown screws: cortex/unknown lot.Part and lot number are unknown; udi number is unknown.On (b)(6) 2018 on some parts.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used for: the complaint indicated that the device broke post-op requiring additional surgical intervention.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent a revision orif (open reduction internal fixation) of a right humerus on (b)(6) 2018 due to a broken 4.5mm cortex screw and nonunion.The patient was initially implanted with the following hardware on (b)(6) 2017; one (1) 11-hole 4.5mm narrow locking compression plate (lcp), six (6) 4.5mm self-tapping cortex screws, one (1) 3.5mm self-tapping cortex screw, and two (2) 2.7mm self-tapping cortex screws.Lengths of the screws are unknown.The 3.5mm and 2.7mm screws were implanted directly into the patient¿s bone to reduce the fracture and not implanted in the plate.X-rays were taken on an unknown date and revealed the broken screw and nonunion.Patient was described as ¿slow¿ with minimal support at home.The plate, five (5) 4.5mm cortex screws, and one (1) 3.5mm cortex screws (removed intact) were removed.The head of the broken 4.5mm screw was floating freely in soft tissue and could not be retrieved.The body of the screw was still in solid bone and was not retrieved.The two (2) 2.7mm cortex screws were not removed and remained part of the revised construct.No surgical delay and the procedure was completed successfully.In addition, after further review of x-rays, it has been determined that five (5) 4.5mm self-tapping cortex screws loosened/backed out of the plate.Concomitant devices reported: 4.5mm narrow locking compression plate (lcp) 11 holes/206mm (part # 224.611, lot # unknown, quantity # 1), 3.5mm self-tapping cortex screws (part # unknown, lot # unknown, quantity # 1), 2.7mm self-tapping cortex screws (part # unknown, lot # unknown, quantity # 2).This complaint involves one (1) device.This report is 2 of 2 for (b)(4).
 
Event Description
This complaint involves two (2) devices.This report is for five (5) unknown 4.5mm cortex screws that loosened/backed out.
 
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.This report is for five (5) unknown 4.5mm cortex screws/unknown lot.Part and lot number are unknown; udi number is unknown.Date of event : unknown when 4.5mm cortex screws loosened/backed out and nonunion began.Patient code 3191 not needed to be reported; patient code 1924 (implant, failure of) reported to capture post-operative loosening/backing out requiring revision.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.Concomitant medical products : therapy date: (b)(6) 2017.Based on the reported concomitant 4.5mm narrow locking compression plate (244.611), the 4.5mm cortex screw family was identified as belonging to the following family: 4.5mm cortex screws, self-tapping (214.814-945 ) per the large fragment lcp system inventory control form.As the devices are not available for return, the provided x-rays were examined with the following findings: the complaint condition of broken was able to be confirmed as a distal screw was found to be broken.The screw head fragment was observed to have migrated towards the joint space.The plate was no longer reduced to the patient¿s humerus, as such the remaining screws in the plate construct appear to have loosened/backed out.Based on the complaint description no potential root cause was able to be identified.No device history review was able to be completed as the device part and lot combination is unknown.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no design or manufacturing defects or deficiencies were identified during the investigation.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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Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7445913
MDR Text Key106006669
Report Number2939274-2018-51838
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
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 04/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient Weight75
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