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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH COMPRINSTR F/PFNA BLADE; MISC ORTHO SURGICAL INSTR
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SYNTHES GMBH COMPRINSTR F/PFNA BLADE; MISC ORTHO SURGICAL INSTR Back to Search Results
Catalog Number 03.010.423
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/12/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2020 during an unknown procedure, the compression instrument for pfna blade broke.It was reported that the top of the instrument came off and a small part of the instrument remained in the pfna blade inside the patient.The procedure was completed.There was patient consequence.There is no further information available.Concomitant device reported: unknown pfna blade (part # unknown, lot # unknown, quantity # 1).This report is for one (1) comprinstr f/pfna blade.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device has been 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.
 
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: investigation summary: investigation site: cq zuchwil.Selected flow: damaged.Visual inspection: the visual inspection confirmed that the threaded tip of is broken off.The broken threaded part is missing.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: due to the missing part and the condition of the returned device, a dimensional test is not appropriate, as all complaint-relevant dimensions cannot be measured and can no longer correspond to the valid technical drawings specifications due to the damage incurred.Document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The review of the manufacturing documents has shown that the correct material was used and that the hardness was within the specification.Summary: the returned device was examined and the complaint condition was able to be confirmed as the threaded tip is broken off.This lot of (b)(4) pieces was manufactured in august 2009 and we are not aware of any other complaint for this part- and lot number combination.This and the findings above let us exclude a manufacturing related issue.This failure is typically consistent with inadequate handling of the device in combination with excessive force application.During the investigation, no manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot.Part: 03.010.423, lot: 2514187, manufacturing site: bettlach.Release to warehouse date: august 10, 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
COMPRINSTR F/PFNA BLADE
Type of Device
MISC ORTHO SURGICAL INSTR
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11100921
MDR Text Key224569199
Report Number8030965-2020-10068
Device Sequence Number1
Product Code LXH
UDI-Device Identifier07611819370968
UDI-Public(01)07611819370968
Combination Product (y/n)N
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.010.423
Device Lot Number2514187
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - NAIL HEAD ELEMENTS: PFNA BLADE
Patient Outcome(s) Required Intervention;
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