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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR BLADE 50MM CRANIAL/CAUDAL-LEFT

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR BLADE 50MM CRANIAL/CAUDAL-LEFT Back to Search Results
Model Number 03.615.350
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee.Part number: 03.615.350, lot number: t951371.Manufacturing site: tuttlingen.Release to warehouse date: 29-oct-2010.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the blade cranial/caudal le l50 (p/n: 03.615.350, lot number: t951371) was received at us customer quality (cq).Visual inspection of the complaint device showed a small piece had broken off one of the corners.Device failure/defect identified? yes.A dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.This complaint is confirmed as a small piece had broken off one of the corners.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 (b)(6) reports an event as follows: it was reported that on an unknown date that the instrument tip was damaged.This was noticed when the sets were opened to be used for surgery.It had no patient impact as is was not the size the surgeon needed to use.This report is for one (1) retractor blade 50mm cranial/caudal-left.This is report 1 of 1 for (b)(4).
 
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Brand Name
RETRACTOR BLADE 50MM CRANIAL/CAUDAL-LEFT
Type of Device
RETRACTOR
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
SZ   78532
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11555890
MDR Text Key244708770
Report Number2939274-2021-01488
Device Sequence Number1
Product Code GAD
UDI-Device Identifier10705034715759
UDI-Public10705034715759
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 03/23/2021
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 Number03.615.350
Device Catalogue Number03.615.350
Device Lot NumberT951371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/23/2021
Initial Date FDA Received03/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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