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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 2.7MM & SMALL SCREWS; GAUGE,DEPTH
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE,DEPTH Back to Search Results
Model Number 319.01
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, a depth gauge for cortex screw is bent/broken.It is unknown if there was patient involvement.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Service and repair evaluation: the customer reported the device was bent/broken.The repair technician reported the device tip was bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.The depth gauge for 2.7mm & small screws (part # 319.01 lot # l165397) was received at us cq.The distal tip of the device was minorly bent/deformed.There was enough damage to the tip that would render the device inoperable.There were light surface scratches consistent with normal wear along the body of the device.No other issues to note.There was no evidence of fracture/device breakage.The reported condition of broken is not confirmed however, the overall complaint is confirmed as the device was still bent and damaged such that the device is not usable.Manufacturing record evaluation: the received depth gauge for 2.7mm & small screws (part # 319.01 lot # l165397) was manufactured at the haegendorf site on 06-jan-2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The overall complaint was confirmed for the received depth gauge for 2.7mm & small screws (part # 319.01 lot # l165397) as the distal tip of the device was mildly bent.The bent condition renders the device inoperable.There was no evidence of device breakage.Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces during use.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.Device history lot: part: 319.010, lot: l165397, manufacturing site: haegendorf, release to warehouse date: 06.Jan.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
10/04/2019: updated event description: it was reported that on an unknown date, a depth gauge for cortex screw appears to be bent/broken.It was discovered at sacred heart medical center (shmc) ortho station.There was no patient involvement.This complaint involves once (1) device.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b5: updated event description provided for reporting.H3, h4, h6: without a lot number, the device history records review could not be completed as no product was received.H3, h6: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.H11: updated the medical history and relevant test/lab data from ni to n/a.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.
 
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Brand Name
DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
Type of Device
GAUGE,DEPTH
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key9156292
MDR Text Key196199404
Report Number2939274-2019-61180
Device Sequence Number1
Product Code HTJ
UDI-Device Identifier10886982189950
UDI-Public(01)10886982189950
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number319.01
Device Catalogue Number319.01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Date Manufacturer Received10/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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