• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM DRILL BIT/QC/GOLD/110MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM DRILL BIT/QC/GOLD/110MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Back to Search Results
Model Number 310.25
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/13/2021
Event Type  Injury  
Manufacturer Narrative
Procode: additional product code: hsz, gff, hwe.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the tip of the 2.5mm drill bit broke inside the patient when drilling for a 3.5mm screw.Surgeon made the decision to leave the broken drill tip inside the bone.The broken drill bit was discarded and a new one was used.Procedure successfully completed without any delay.This report is for one (1) 2.5mm drill bit/qc/gold/110mm.This is report 1 of 1 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2.5MM DRILL BIT/QC/GOLD/110MM
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11959353
MDR Text Key263501245
Report Number2939274-2021-02828
Device Sequence Number1
Product Code GFA
UDI-Device Identifier10886982186317
UDI-Public(01)10886982186317
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number310.25
Device Catalogue Number310.25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/14/2021
Initial Date FDA Received06/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-