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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC TRIAL INSERTER SH CONNECTION; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
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DEPUY SPINE INC TRIAL INSERTER SH CONNECTION; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR Back to Search Results
Model Number AET20101
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is company representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that one of the inner shafts of an implant inserter is not threading on to the wheel.Indeed, both of the implant inserters are fully functioning.One of the tips of one of the yellow handle trial implant inserters (aet20101) is slightly bent.The damage was discovered during the inspection.The other trial implant inserter is in perfect condition.It was unknown if the surgery completed successfully.There were no patient consequences are reported.Concomitant device reported: unknown conduit cage alif (part#: unknown, lot#: unknown, quantity unknown); unknown implant inserter connection eit (part#: unknown, lot#: unknown, quantity unknown); unknown implant inserter (part#: unknown, lot#: unknown, quantity 2).This complaint involves five(5) devices.This report is for (1) trial inserter sh connection.This is report 1 of 5 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.H10 additional narrative: b5: updated event description.D4: updated lot number.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
Updated event description: concomitant device reported: unknown conduit cage alif (part#: unknown, lot#: unknown, quantity unknown), unknown implant inserter connection eit (part#: unknown, lot#: unknown, quantity unknown), implant inserter (part#: aet30100, lot#: e16di0200, quantity 1).
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary.Visual inspection: the complete device (including aet20101 a alif trial inserter sh connection, and aet20101 b alif trial inserter pin sh connection) was received at us cq.Visual observations revealed that threaded portion at the distal end and proximal end was found be worn/damage.The distal tip of the inserter sh connection was found to be bent.And inner threads at proximal end was found to be slightly stripped.Functional testing: both of them were assembled together.It was assembling/disassembling properly to the mating device.However, received devices are found to be stripped which may have caused the issues in disassembling during surgery.Investigation conclusion: the complaint condition is confirmed.Per guidance provided in windchill document, it is determined that the threads and tip are stripped/worn/deformed from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: a review of the trial inserter sh connection was conducted identifying that lot number e16di0203 was released in a single batch.Batch1: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.H11 corrected data.D10.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
TRIAL INSERTER SH CONNECTION
Type of Device
INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key10196527
MDR Text Key197148022
Report Number1526439-2020-01266
Device Sequence Number1
Product Code MAX
UDI-Device Identifier04260557774779
UDI-Public(01)04260557774779
Combination Product (y/n)N
PMA/PMN Number
K172888
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAET20101
Device Catalogue NumberAET20101
Device Lot NumberE16DI0203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Initial Date Manufacturer Received 06/15/2020
Initial Date FDA Received06/25/2020
Supplement Dates Manufacturer Received07/10/2020
07/31/2020
Supplement Dates FDA Received07/27/2020
08/17/2020
Patient Sequence Number1
Treatment
HAMMER; HAMMER; IMPLANT INSERTER; IMPLANT INSERTER; IMPLANT INSERTER SH CONNECTION; UNKNOWN CAGE/SPACER; UNKNOWN CAGE/SPACER; UNKNOWN INSERTION INSTRUMENTS; UNKNOWN INSERTION INSTRUMENTS
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