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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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: reporter is a synthes employee. Product code: 319. 004 synthes lot: 4011453 supplier lot: n/a. Release to warehouse date: (b)(6) 1999. Manufactured by: synthes brandywine no nonconformance reports (ncrs) 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. Visual inspection: the depth gauge for 1. 3mm and 1. 5mm screws was returned and received at us customer quality (cq). Upon visual inspection, it was observed that the needle component of the device was bent. Also, the protection sleeve was not returned with the complaint device. No other issues were observed with the returned device. Dimensional inspection: drawing: needle (1. 3/1. 5) feature: needle diameter measured dimension: conforming document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed. -depth gauge for 1. 3mm and 1. 5mm screws -needle (1. 3/1. 5) -protection sleeve no design issues or discrepancies were identified. Investigation conclusion: this complaint was confirmed since the device was returned bent and without the protection sleeve. No definitive root cause could be determined based on the provided information. There was no indication that a design or manufacturing issue contributed to the complaint. 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 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 during a routine incoming inspection of a loaner set at a field stocking location (fsl) on an unknown date, it was observed that the depth gauge was missing a component. There is no known patient or hospital involvement. Upon manufacturer investigation, it was determined that the needle component of the device was bent. This report is for a depth gauge for 1. 3mm and 1. 5mm screws. This is report 1 of 1 for pc-(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 Key12975508
MDR Text Key287800749
Report Number2939274-2021-07030
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 Number319.004
Device Catalogue Number319.004
Device Lot Number4011453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/1999
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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