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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM DRILL SLEEVE 42MM LONG; GUIDE, SURGICAL, INSTRUMENT
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM DRILL SLEEVE 42MM LONG; GUIDE, SURGICAL, INSTRUMENT Back to Search Results
Model Number SD312.021
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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) 2021, during an unknown procedure the drill sleeve top hat broke, retrograde/antegrade femoral nail (rafn) entry reamer is dull, drive adaptor with qc for 5.0mm schanz screws and drive adaptor with qc for 6.0 schanz screws were stripped.The percutaneous depth gauge, depth gauge for locking screws, and depth gauge for cortex screws were bent.It is unknown how the procedure was completed.There was a surgical delay of fifteen (15) minutes.This report involves one (1) 2.0mm drill sleeve 42mm long.This is report 4 of 8 for (b)(4).This product complaint is related to (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.H10 additional narrative: 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.B5, h6.
 
Event Description
It was reported that on (b)(6) 2021, during an unknown procedure the drill sleeve top hat broke, retrograde/antegrade femoral nail (rafn) entry reamer is dull, drive adaptor with qc for 5.0mm schanz screws and drive adaptor with qc for 6.0 schanz screws were stripped.Percutaneous depth gauge, depth gauge for locking screws, and depth gauge for cortex screws were broken.It is unknown how the procedure was completed but there was a surgical delay of 15 minutes.
 
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Brand Name
2.0MM DRILL SLEEVE 42MM LONG
Type of Device
GUIDE, SURGICAL, INSTRUMENT
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key11413124
MDR Text Key241561387
Report Number2939274-2021-01164
Device Sequence Number1
Product Code FZX
UDI-Device Identifier10886982261274
UDI-Public(01)10886982261274
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSD312.021
Device Catalogue NumberSD312.021
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
13.0MM CANNULATED DRILL BIT 300MM; DEPTH GAUGE FOR 2.7MM AND SMALL SCREWS; DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; DEPTH GAUGE FOR LOCKING SCREWS TO 100MM; DRIVE ADAPTOR W/ QC FOR 5.0MM SCHANZ SCR; DRIVE ADAPTOR W/ QC FOR 6.0MM SCHANZ SCR; PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCR
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