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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 1.3MM AND 1.5MM SCREWS GAUGE, DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE, DEPTH Back to Search Results
Model Number 319.004
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2021
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. A device history record (dhr) review was conducted: the depth gauge for 1. 3mm and 1. 5 mm screws (p/n: 319. 004, lot #: 4206824 was returned and received. Upon visual inspection, it was observed that the distal tip of the needle component was bent and deformed. Additionally, slight scratches were observed on the device. No other issues were identified with the returned device. The sliding bar does not slide smoothly because of the deformity of the tip, it might also cause not to fit on the 1. 1mm drill hole. Can the complaint condition be replicated? no, the complaint condition cannot be replicated during functional test. Dimensional inspection was not performed due post manufacturing damage. Based on the date of manufacture, the current and manufactured revision of drawings were reviewed. The reported condition of the complaint device (depth gauge for 1. 3mm and 1. 5mm screws) is confirmed. The distal tip of the needle component was bent and deformed causing struggle to slide. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. The potential cause could be due to unintended forces applied to the device and the potential cause for missing protection sleeve could be due to device incorrectly assembled during the sterilization process. 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 -no ncrs were generated during production. Device history review - 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. If information is obtained a follow-up medwatch will be filal medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that on (b)(6) 2021, a patient underwent an open reduction and internal fixation metacarpal procedure. During the procedure the depth gauge would not fit through 1. 1mm drill hole. A mini fragment set was pulled to complete the procedure with a different style depth gauge. The procedure was completed successfully with a surgical delay of five (5) minutes. This report is for one (1) depth gauge for 1. 3mm and 1. 5mm screws. This is report 2 of 2 for complaint (b)(4).
 
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Brand NameDEPTH GAUGE FOR 1.3MM AND 1.5MM 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13142156
MDR Text Key285644762
Report Number2939274-2022-00001
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number319.004
Device Catalogue Number319.004
Device Lot Number4206824
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2000
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/03/2022 Patient Sequence Number: 1
Treatment
UNK - PLATES: MODULAR HAND SYSTEM; UNK - SCREWS: HAND; UNKNOWN - DRILL GUIDES
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