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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH Back to Search Results
Model Number 319.006
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Reporter is synthes employee. Investigation summary : investigation flow: damage. Visual inspection: the depth gauge for 2. 0mm and 2. 4mm screws (part # 319. 006) was received at us cq. The device was received missing its body and protection sleeve components. The returned components did not have a lot number etched so it was not possible to visually confirm the reported device's lot number the needle was received bent right at the mating point between the needle and the slider. After mild physical manipulation during the visual inspection the needle broke off the slider. Device failure/defect identified? yes; components were missing and the needle was broken. Document/specification review: drawing(s) reviewed: (current & manufactured revisions). Conclusion: the overall complaint was confirmed for the received depth gauge for 2. 0mm and 2. 4mm screws as the device was missing components and its needle was broken. Although no definitive root-cause can be determined the device may have experienced unintended forces. The needle was bent/damaged so severely that light physical touch caused the needle to break off the assembly. 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 history lot: part #319. 006. Synthes lot # h786309. A dhr file could not be reviewed as it has not yet been scanned into tungsten as of feb 03, 2020 , but jde confirmed that the lot was released for sale aug 30, 2019, if a dhr file becomes available in the future, the review (of the dhr) will be revisited. A search in mdd non-conformance module confirmed that no non-conformance occurred during manufacture. 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, during routine incoming inspection of a loaner set, it was observed that a depth gauge was bent. Another depth gauge was received with missing components. There was no patient involvement. This complaint involves two (2) devices. This is 1 of 1 for report (b)(4).
 
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Brand NameDEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
Type of DeviceGAUGE,DEPTH
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9847456
MDR Text Key188675547
Report Number2939274-2020-01317
Device Sequence Number1
Product Code HTJ
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 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number319.006
Device Catalogue Number319.006
Device Lot NumberH786309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/30/2019
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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