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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 LARGE SCREWS GAUGE, DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LARGE SCREWS GAUGE, DEPTH Back to Search Results
Model Number 319.10
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee. Part: 319. 10. Lot: 7979726. Manufacturing site: (b)(4). Supplier: n/a. Release to warehouse date: july 24, 2012. Expiration date: n/a. A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. Visual inspection: the complaint device, depth gauge for large screws was returned to customer quality (cq) (b)(4) for investigation. Upon visual inspection, the gauge was missing a component and the needle was slightly bent. Service and repair evaluation: the customer reported the depth gauge is missing a component. The repair technician reported the device was missing the head piece. The cause of the issue could not be determined. The reason for repair is missing component. The item is being scrapped as the s&r site did not have the components to repair. The device could not be repaired per the inspection sheet and will be forwarded to customer quality. The evaluation was confirmed. Document/specification review: based on the date of manufacture, the current and manufactured version of drawings were reviewed. Dimensional inspection: it is evident from the visual inspection that the depth gauge was missing a component, hence a dimensional inspection was not performed. Investigation conclusion: the complaint can be confirmed based on the available information. The depth gauge was missing the head piece and the needle of the gauge appeared slightly bent. 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. This report is for an unknown device/unknown lot. Part and lot number are unknown; udi number is unknown.
 
Event Description
It was reported that during a routine incoming inspection of the loaner set at a field stocking location (fsl) on an unknown date, it was observed that the depth gauge for large screws was missing a component. There was no patient involvement. Upon manufacturer investigation, it was determined that the needle of the device was bent. This report is for a depth gauge for large screws. This is report 1 of 1 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR LARGE 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)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12975429
MDR Text Key286861398
Report Number2939274-2021-07028
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 Other Health Care Professional
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number319.10
Device Catalogue Number319.10
Device Lot Number7979726
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2012
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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