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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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS Back to Search Results
Catalog Number 319.006
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Product complaint: (b)(4). Investigation summary background: it was reported that on an unknown date, during routine incoming inspection of loaner set it was observed that the depth gauge was missing a piece. There was no patient involvement. This complaint involves one (1) device. Investigation flow: damage. Visual inspection: the depth gauge for 2. 0mm and 2. 4mm screws (part # 319. 006/ lot # h363284) was received at us cq. The needle of the device was broken off and was not returned. The ball component was missing from the body. No other defects were identified. The received condition was consistent with the complaint condition thus the complaint was confirmed. Needle was broken, ball was missing. Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage. Conclusion: the overall complaint was confirmed for the received depth gauge for 2. 0mm and 2. 4mm screws as the needle was broken and the ball was missing. Although no definitive root-cause can be determined its possible the device experienced unintended forces leading to the device breakage. 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 review of the device history record. Device history lot: part #: 319. 006. Synthes lot number: h363284. Supplier lot number: h363284. Manufacturing site: synthes monument. Release to warehouse date: 21-nov-2017. Supplier: (b)(6). Device history batch null, device history 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 that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that on an unknown date, during routine incoming inspection of loaner set it was observed that the depth gauge was missing a piece. There was no patient involvement. This complaint involves one (1) device.
 
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Brand NameDEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
Type of DeviceDEPTH GAUGE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9766139
MDR Text Key191684197
Report Number2939274-2020-01096
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,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.006
Device Lot NumberH363284
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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