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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT; TEMPLATE
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SYNTHES GMBH T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT; TEMPLATE Back to Search Results
Catalog Number 03.812.308
Device Problem Compatibility Problem (2960)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that during a procedure on (b)(6) 2021, after the disc prep, surgeon proceeded on to testing out the trials and noticed that the trial cage started turning as he was hammering it in even before him turning the knob on the instrument.It was resolved by using a different trial and applicator instrument.The case was finished without any surgical delay.No further information provided.This report is for (1) t-pal trial spacer 10mm x 28mm 8mm height.This is report 3 of 3 for complaint (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.H3, h6: part: 03.812.308, lot: 8021191, manufacturing site: hagendorf, release to warehouse date: 16 october 2012.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the t-pal small trial implant siz 8 non deta (part# 03.812.308, lot# 8021191 qty# (b)(4)) was returned and received at us customer quality (cq).Upon visual inspection, nicks/scratches and slight discoloration were observed on the device surfaces indicating signs of normal use which would not contribute to the complaint condition.No other issues were identified with the device.Functional test: a functional test was performed on the returned devices.The knob was securely fixed onto the threaded end of the applicator handle with no issues while fastening.The trial spacer was then inserted into the applicator handle shaft while ensuring the arrow on the handle shaft is aligned with the arrow on the trial.The trial spacer sat flush against the applicator with no gap.The knob was then turned clockwise until the security ring clicked up to reveal the green band on the applicator and until the knob was tightened.The trial spacer was fixed in its 0 degree position and could not pivot.Firm connection of the trial to applicator was checked manually by applying pressure on the lateral side of the trial with the thumb.The trial would not pivot.The devices function as intended.The applicator handle and the applicator knob are investigated separately.Can the complaint be replicated with the returned device(s)? no.A functional test of the returned devices determined the devices to function as intended.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq as the complaint condition could not be replicated and the devices functioned as intended.Document/specification review: the following drawing(s) (current and manufactured to) were reviewed: - trial implant-us, small size kpl t-pal no design issues or discrepancies were found during this investigation.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for the t-pal small trial implant siz 8 non deta (part# 03.812.308, lot# 8021191 qty# 1) as the devices passed the functional test and functioned as intended.While a definitive root cause could not be identified for the reported issue, it is possible that the surgical technique for the assembly of the devices was not followed appropriately.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 upon these results, 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.
 
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: 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.
 
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Brand Name
T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT
Type of Device
TEMPLATE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key12276330
MDR Text Key266740764
Report Number8030965-2021-06415
Device Sequence Number1
Product Code HWT
UDI-Device Identifier07611819418981
UDI-Public(01)07611819418981
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,foreig
Type of Report Initial,Followup,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.812.308
Device Lot Number8021191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Date Manufacturer Received09/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APPLICAT OUT SHAFT; APPLICATOR KNOB; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA
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