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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPINDLE NUT APPARATUS, TRACTION, NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPINDLE NUT APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 394.42
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. The product was returned to depuy synthes for evaluation. The depuy synthes team conducted a visual inspection of the returned device. Visual analysis of the returned sample revealed that nut-knurled f/large-distract was stuck on the returned mating device. A dimensional inspection was unable to be performed due to the complaint condition. A functional test was performed and the complaint device was unable to be removed from the mating device. The complaint condition was able to be replicated. As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications. The overall complaint was confirmed as the observed condition of the nut-knurled f/large-distract would contribute to the complained device issue. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. 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
It was reported that on an unknown date, they have a synthes threaded rod and a washer sleeve that is attached firmly. The operating room dept was not able to remove this washer from the rod. This report involves one (1) spindle nut. This is report 1 of 2 for (b)(4).
 
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Brand NameSPINDLE NUT
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14517435
MDR Text Key295413853
Report Number2939274-2022-01944
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number394.42
Device Catalogue Number394.42
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? Yes
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: 05/26/2022 Patient Sequence Number: 1
Treatment
UNK - RODS
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