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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Model Number 352.040
Device Problems Break (1069); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 im nail of the tibia while passing through the proximal reamer over the guidewire, the guidewire was bent. This caused reamer to disengaged to hex on the shaft which was twisted the head of the reamer shaft. The reamer exploded into pieces inside the canal. All pieces were retrieved from the patient. Upon inspection of the flexible shaft, it was damaged while trying to fit into the modular reamer heads twisted around one another. This report is for one (1) 5. 0mm flexible shaft. This is report 1 of 3 for complaint (b)(4).
 
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Brand Name5.0MM FLEXIBLE SHAFT
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12446692
MDR Text Key270564460
Report Number2939274-2021-05244
Device Sequence Number1
Product Code HTO
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,health
Type of Report Initial,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number352.040
Device Catalogue Number352.040
Device Lot NumberL762704
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2018
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: 09/09/2021 Patient Sequence Number: 1
Treatment
8.5MM MEDULLARY REAMER HEAD; UNK GUIDES/SLEEVES/AIMING: EIT
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