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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7MM VA-LCP BENDING PLIER PLIERS, SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7MM VA-LCP BENDING PLIER PLIERS, SURGICAL Back to Search Results
Model Number 03.211.005
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank. Reporter is a synthes employee. Part: 03. 211. 005, lot: t948737, manufacturing site: (b)(4), release to warehouse date: september 27, 2010. A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified. Visual inspection: the 2. 4/2. 7mm va-lcp bending plier was received at us customer quality (cq). Visual inspection of the complaint device showed the compression springs part 329_146_9 and 329_146_8 were deformed. Functional test: during the functional assessment, compression was applied to both handles by squeezing them but not locking them. After release of the grip to unload the compression, the handles did not retract back to their resting position. The functional test failed. Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage. Also, measurement of relevant parts of the device would require the device to be disassembled. Document/specification review: current and manufactured revisions were reviewed. No design issues or discrepancies were identified. Investigation conclusion: this complaint is confirmed as the springs of the device were found deformed. 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 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 during inspection of back up items on unknown date, some were set aside for expired exchange. One (1) bending pliers have no tension. Two (2) topcoat from the depth gauges are peeling. One (1) handle with quick coupling gets stuck. One (1) universal drill guide has pitting on the handle. One (1) stardrive screwdriver is losing its shape. And two (2) socket wrenches have pitting on the swivel. There was no patient involvement. This report is for a 2. 4/2. 7mm va-lcp bending plier. This is report 1 of 3 for (b)(4).

 
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Brand Name2.4/2.7MM VA-LCP BENDING PLIER
Type of DevicePLIERS, SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11791784
MDR Text Key249741489
Report Number2939274-2021-02261
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
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 04/13/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/07/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number03.211.005
Device Catalogue Number03.211.005
Device LOT NumberT948737
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/22/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/27/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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