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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH IMPACTOR F/PFNA BLADE
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SYNTHES GMBH IMPACTOR F/PFNA BLADE Back to Search Results
Catalog Number 356.823
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee.Device is not distributed in the united states, but is similar to device marketed in the usa.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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the surgery for the trochanteric fracture with the blade, sleeve, impactor and nut.During the surgery, when the surgeon inserted the blade by hand, he felt resistance.The surgeon hammered the blade, but the blade could not be inserted.The surgeon tried to remove the blade once, but the blade could not be removed.The surgeon removed the devices and used other devices.The surgery was completed successfully with a 150 minute delay.After the surgery, the sales rep confirmed that the blade was inserted to the sleeve at unproper direction.The lemon shape part of the blade stuck into the sleeve.The sales rep could not pull out the blade from the sleeve.The scheduled surgery time was from thirty (30) minutes to one (1) hour.Concomitant devices reported: pfna-ii blade l90 tan (part number 04.027.053s, lot 71p9662, quantity 1); protect sleeve 16/11 f/pfna blade (part number 356.818, lot 9375862, quantity 1); buttress/compr-nut f/pfna blade (part number 356.817, lot 8011770, quantity 1).This report involves one (1) impactor f/pfna blade.This is report 3 of 4 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.Investigation site: cq zuchwil selected flow: device interaction/functional.Visual inspection: the returned impactor was received with an assembled condition of protect sleeve / pfna - blade and buttress/compr-nut.The pfna - blade as well as the protect sleeve / impactor are in an desolate condition.All over the surface strongly hammer blows and marks visible.The citrus shape of pfna blade is in a wrong direction to the protect sleeve citrus shape hole.Functional test: a functional test cannot be performed of the detected damage.Based at the severity of damage further attempts failed to release the jammed / damaged instruments.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related handling fault at the device.Summary: the received condition agree with the complaint description and the complaint therefore is confirmed.The citrus shape of pfna blade is in a wrong direction to the protect sleeve citrus shape hole.The complaint is not a result of a product related deficiency, we can assume that a handling failure caused this occurrence.In this relation we would like to mention following important statement of the pfna surgical technique: do not use unnecessary force when inserting the pfna-ii blade.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "document/specification review: / dimensional inspection:" are not required.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot product code: 356.823, lot number: 2257477, manufacturing site: bettlach, release to warehouse date: apr.17, 2007.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.
 
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: 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.G1.
 
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Brand Name
IMPACTOR F/PFNA BLADE
Type of Device
IMPACTOR
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11100564
MDR Text Key224547934
Report Number8030965-2020-10063
Device Sequence Number1
Product Code HWA
UDI-Device Identifier07611819291317
UDI-Public(01)07611819291317
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 12/04/2020
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 Catalogue Number356.823
Device Lot Number2257477
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Initial Date Manufacturer Received 12/04/2020
Initial Date FDA Received12/31/2020
Supplement Dates Manufacturer Received02/02/2021
02/26/2021
Supplement Dates FDA Received02/17/2021
02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BUTTRESS/COMPR-NUT F/PFNA BLADE; PFNA-II BLADE L90 TAN; PROTECT SLEEVE 20/17 F/PFNA-II; BUTTRESS/COMPR-NUT F/PFNA BLADE; PFNA-II BLADE L90 TAN; PROTECT SLEEVE 20/17 F/PFNA-II
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