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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369 APPARATUS, TRACTION, NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369 APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 357.371
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter is synthes sales representative. Part 357. 371, lot 7681977: release to warehouse date: october 09, 2014. Supplier: (b)(4). Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. A product investigation was completed: upon visual inspection, it was observed that the device interface feature (distal end railing) edge was slightly deformed. No other damages were observed on the device except normal wear which would not contribute to the reported complaint condition. The function test was performed with the returned complaint device (buttress/compress nut) and the mating device (130 deg aiming arm: 357. 366). During the functional test, the mating device was assembled with the complaint device and it was observed that assembly was too loose as the devices were not interfaced as intended. The alleged device interaction issue was caused due to the interface features deformation in both mating and complaint devices. Thus, the complaint condition was confirmed for the received device. The dimensional inspection was not performed as the complaint relevant dimensions cannot be checked for dimensional accuracy due to the post-manufacturing damage. The relevant drawings reflecting current and manufactured revisions were reviewed. The overall complaint was confirmed for the received device as the complaint device was unable to assemble with the mating device as intended. The resulted device interaction issue was occurred due to the deformed interface features in both mating and complaint devices. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. 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 on (b)(6) 2020, the patient underwent an unknown procedure. During the procedure, the buttress/compression nut and the aiming arm would not click in. The procedure was successfully completed with no surgical delay. There was no patient consequence. This report is for a buttress/compression nut. This is report 2 of 2 for (b)(4).
 
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Brand NameBUTTRESS/COMPRESSION NUT FOR 357.369
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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10922867
MDR Text Key218978320
Report Number2939274-2020-05364
Device Sequence Number1
Product Code HST
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number357.371
Device Catalogue Number357.371
Device Lot Number7681977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2014
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: 11/30/2020 Patient Sequence Number: 1
Treatment
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
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