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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
Catalog Number 319.006
Device Problems Component Missing (2306); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Occupation: reporter is a j&j employee. A product investigation was conducted. Visual inspection: the depth gauge for 2. 0 mm and 2. 4 mm screws (part #: 319. 006, lot #: 5682849) was received at us cq. Upon visual inspection, it was observed that the device was missing the protection sleeve component and the tip of the device had bent at the proximal base. No other issues were identified. Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage and device geometry. Document/specification review: the relevant drawing(s) were reviewed: no design issues or discrepancies were identified. Investigation conclusion: this complaint is confirmed as the complaint device was missing the protection sleeve component and the tip of the device was bent at the proximal base. While no definitive root cause could be determined, it is possible the device encountered unintended forces during use and/or the missing components of the device were displaced when taken apart for sterilization. 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 preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. A device history record (dhr) review was conducted: part # 319. 006, synthes lot # 5682849, supplier lot # n/a, release to warehouse date: 18 jan 2008, manufactured by synthes (b)(4). No ncr's were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. Device was used for treatment, not diagnosis.
 
Event Description
It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the depth gauge was missing a piece. There was no known patient or hospital involvement. During manufacturer's investigation of the returned device it was observed that the device was missing the protection sleeve component and the tip of the device had bent at the proximal base. This product condition was re-evaluated and found to be reportable on (b)(6) 2020. This report is for one (1) depth gauge for 2. 0 mm and 2. 4 mm screws. This is report 1 of 1 for (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)
BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10550648
MDR Text Key208010131
Report Number2939274-2020-04189
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
Reporter Occupation
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.006
Device Lot Number5682849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2008
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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