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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 03.037.010
Device Problems Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a trauma procedure, the surgeon experienced difficulty removing the cannulated connecting screw after insertion. Upon completion, the connecting screw threads were found to be damaged. The ball hex screwdriver was damaged while removing the connecting screw. There was a surgical delay of (15) minutes. The procedure was successfully completed by using pliers to help remove the bolt. No fragments were generated. There was no patient consequence. This report is for (1) cannulated connecting screw. This is report 2 of 2 for (b)(4).
 
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Brand NameCANNULATED CONNECTING SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12704247
MDR Text Key278596815
Report Number2939274-2021-06326
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.010
Device Lot NumberL278492
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
Treatment
SCR-DRIVER-HEX W/SPHERIC-HEAD Ø8
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