• 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 DRIVE SHAFT FOR RIA 2 520MM ACCESSORIES, ARTHROSCOPIC

  • 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 DRIVE SHAFT FOR RIA 2 520MM ACCESSORIES, ARTHROSCOPIC Back to Search Results
Model Number 03.404.035
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code: hto. Reporter is a j&j representative. Investigation summary investigation flow: device interaction/functional & damage visual inspection: the drive shaft for ria 2 520mm (p/n: 03. 404. 035, lot number: j000427) was received at us cq. Visual inspection of the complaint device showed outer part of the distal tip was deformed, which could not have contributed to the complaint condition. No other issues were identified with the complaint device. The provided photograph was reviewed, and no additional issues were observed. Functional test: a functional assessment was not performed on the complaint device since the device was returned by itself without the reamer head. However, the deformed condition of the complaint device could not cause the complaint condition. The complaint unable to perform with the returned device(s). Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage. Document/specification review: no design issues or discrepancies were identified. Complaint was not confirmed. Investigation conclusion: this complaint was not confirmed as outer part of the distal tip was deformed and could not contribute to the complaint condition. 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 history lot part # 03. 404. 035. Synthes lot # j000427. Supplier lot # j000427. Release to warehouse date: aug 11, 2020. Supplier: mark two engineering inc. No ncr's were generated during production. Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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, the underwent for a surgery. During the surgery, the inner spines of the drive shaft that connect the unknown reamer heads onto the drive shaft stripped out, causing the tines on the unknown reamer heads to break off inside the patient. There was one tine left in the patient. Fragments were generated. There were a 30minutes surgical delay. The procedure successfully completed. No patient consequence. This complaint involves (2) devices. This report is for (1) drive shaft for ria 2 520mm. This report is 1 of 2 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDRIVE SHAFT FOR RIA 2 520MM
Type of DeviceACCESSORIES, ARTHROSCOPIC
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 Key12325192
MDR Text Key266695844
Report Number2939274-2021-04682
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886982274243
UDI-Public(01)10886982274243
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.404.035
Device Catalogue Number03.404.035
Device Lot NumberJ000427
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/16/2021 Patient Sequence Number: 1
Treatment
UNK - REAMERS: REAMER HEAD
-
-