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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLADE/SCREW GUIDE SLEEVE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLADE/SCREW GUIDE SLEEVE Back to Search Results
Model Number 03.037.017
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Reporter is a j&j sales representative.Investigation summary: device interaction/functional.Visual inspection: the blade/screw guide sleeve (part #: 03.037.017, lot #: l274029) was received at us cq.Upon visual inspection of the device and the photo located in notes and attachment section under file "17072417-262a-44c0-b83e-87e29e3f21e6.Jpeg", it was observe that two of the external threads of the device were warped.The buttress compression nut was also found stuck in the threaded portion of the device.Scratches were also observed on the device.Functional test: during functional assessment, the stuck buttress compression nut was able to rotate in clockwise and counter-clockwise directions but could not pass the damaged thread on the device due to the damaged thread.So the buttress compression nut was stuck.The complaint can be replicated with the returned device.Dimensional inspection: no dimensional inspection was performed due to the complaint condition.Document/specification review: no design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint is confirmed as the blade/screw guide sleeve (part #: 03.037.017, lot #: l274029) was found to be have two of its external threads damaged.A mating device was also found to be stuck in the thread area.The reported condition could not be confirmed based on the result of the visual inspection performed.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive 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: 03.037.017-us, lot: l274029, manufacturing site: (b)(4), release to warehouse date: march 28, 2017.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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, the unknown threaded trocar threads was damaged.Procedure was delayed for four(4) minutes.This complaint involves three (3) devices.This report is for one (1) blade/screw guide sleeve.This is report 3 of 3 for complaint (b)(4).
 
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Brand Name
BLADE/SCREW GUIDE SLEEVE
Type of Device
GUIDE
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 Key12453863
MDR Text Key271095729
Report Number2939274-2021-05307
Device Sequence Number1
Product Code FZX
UDI-Device Identifier10886982070333
UDI-Public(01)10886982070333
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.037.017
Device Catalogue Number03.037.017
Device Lot NumberL274029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received09/10/2021
Date Device Manufactured03/28/2017
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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