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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 Problem Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Date of postoperative plate and screw back out is unknown.This report is for an unknown number of trauma screws/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(510k): unknown, as specific part and lot numbers for screw is not provided.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.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 a patient underwent hardware removal and revision on (b)(6) 2018, due to a construct (plate and an unknown number of screws) that backed off of clavicle.The plate was originally implanted on (b)(6) 2018.The original surgery was successful and the surgeon was pleased with the outcome.Post-operatively, the once lateral fracture propagated more medially almost to a midshaft fracture.Noting this the surgeon thought that the patient may have fallen and mal-reduced and increased the length of the fracture.This could not be confirmed but the surgeon removed the originally implanted five-hole clavicle hook plate and revised the patient to a seven-hole clavicle hook plate.It is unknown if there was a surgical delay.The procedure was successfully completed.There was no patient consequence reported.Concomitant device reported: 3.5mm lcp clavicle hook pl 5h 12mm hook depth/59mm/lt-ster (part # 241.083s, lot # unknown, quantity 1).This report is for an unknown number of trauma screws.This is report 1 of 1 for complaint (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 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 a patient underwent hardware removal and revision on (b)(6) 2018, due to a construct (plate and an unknown number of screws) that backed off of clavicle.The plate was originally implanted on (b)(6) 2018.The original surgery was successful and the surgeon was pleased with the outcome.Post-operatively, the once lateral fracture propagated more medially almost to a midshaft fracture.Noting this the surgeon thought that the patient may have fallen and mal-reduced and increased the length of the fracture.This could not be confirmed but the surgeon removed the originally implanted five-hole clavicle hook plate and revised the patient to a seven-hole clavicle hook plate.It is unknown if there was a surgical delay.The procedure was successfully completed.There was no patient consequence reported.
 
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.Event description updated.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 a patient underwent a hardware removal and revision surgery on (b)(6) 2018 due to an unknown quantity of unknown screws backing out from the clavicle.The patient was initially implanted with an original construct containing of one (1) 5-hole 3.5 mm locking compression plate (lcp) clavicle hook plate and an unknown quantity of unknown screws on (b)(6) 2018.The procedure was successfully completed and the surgeon was reportedly please with the outcome.Post-operatively, the once lateral fracture propagated more medially almost to a midshaft fracture.Noting this the surgeon thought that the patient may have fallen and mal-reduced and increased the length of the fracture.This could not be confirmed but the surgeon removed the originally implanted five-hole clavicle hook plate and revised the patient to a seven-hole clavicle hook plate.The 5-hole plate was removed intact and there was no problem with it.The revision procedure was successfully completed, and there was no patient consequence reported.
 
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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 Key7621989
MDR Text Key111815966
Report Number2939274-2018-52567
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 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
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 Received07/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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