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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 LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE, DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE, DEPTH Back to Search Results
Model Number 03.010.072
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Visual inspection: the complaint device depth gauge for lckng scrs to 100 (product code: 03. 010. 072, lot number: l654370) was returned to cq (b)(4) for investigation. No other issues were identified during visual inspection. Device/defect identified: no. Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed. Complaint confirmed: complaint cannot be confirmed based on the available information. Conclusion: there were no issues with the depth gauge and the slider slid over the body without any issues. Hence, the complaint was not confirmed. A definitive root cause cannot be determined from the provided information. 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. Part: 03. 010. 072. Lot: l654370. Manufacturing site: (b)(4). Supplier: n/a. Release to warehouse date: 22 february 2018. Expiration date: n/a. 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 on (b)(6) 2021, three (3) depth gauges were found to be broken during reverse logistics audit of returned device at a third party servicer. There was no patient involvement and no additional information is available. This report is for one (1) depth gauge for locking screws to 100mm for im nails. This is report 3 of 3 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
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 Key12804076
MDR Text Key286604629
Report Number2939274-2021-06659
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 Other
Reporter Occupation
Type of Report Initial
Report Date 10/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.010.072
Device Catalogue Number03.010.072
Device Lot NumberL654370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2018
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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