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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY
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SYNTHES GMBH RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.033.001
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2020
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 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 that on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, while inserting the nail, the impactor/strike bolt was broken off.There was no fragment generation reported.It was unknown if the surgery was completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report involves one (1) radiolucent insertion handle.This report is 1 of 2 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.H3, h6: investigation summary: the received pictures were reviewed and it can be confirmed that a piece of the black composite section of handle is broken off.Next to that is the fragment of the broken driving cap is visible in the insertion handle.The insertion handle has some strong stress marks on the contact surface from the driving cap and next to these stress marks is a clearly visible mark of a strong hammer blow.Based on that it can only be assumed that the piece of the black composite broke off while the device was hit with an hammer.Product was not returned, therefore no further investigation is possible.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 or material is made available, the investigation will be updated as applicable.,investigation site: cq zuchwil selected flow: damaged.Visual inspection: the threaded part of the driving cap is broken off and is still stuck in the insertion handle and cannot be removed.The insertion handle presents some strong stress marks on the contact surface from the driving cap and next to these stress marks is a clearly visible mark of strong hammer blows.In addition, one portion of the black composite section of handle is broken off.Dimensional inspection: the relevant dimensions cannot be verified 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.Summary: the complaint condition is confirmed as the broken threaded tip of the driving cap is still stuck in the insertion handle.In addition, the handle presents some strong stress marks on the surface as well as one portion of the black composite section that was broken off.This production lot was manufactured in august 2019 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.During the investigation, no product design or manufacturing issues were observed that may have contributed to the breakage of the driving cap.Concerning the surface damage we have to assume that the portion of the black composite broke off while the device was hit with the hammer.In this regard the following precaution hint may be referenced from surgical technique dsem/trm/1117/0978 103324-181129 dsem 12/18 page 21: do not strike the insertion handle directly.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: 03.033.001, lot number: 4l45943, manufacturing site: hägendorf, release to warehouse date: aug.30, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified., product code: 03.033.001, lot number: 4l45943, manufacturing site: hägendorf, release to warehouse date: aug.30, 2019.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.H10 additional narrative: b5: updated additional event information e1: updated initial reporter information h3, h6: investigation summary: the received pictures were reviewed and it can be confirmed that a piece of the black composite section of handle is broken off.Next to that is the fragment of the broken driving cap is visible in the insertion handle.The insertion handle has some strong stress marks on the contact surface from the driving cap and next to these stress marks is a clearly visible mark of a strong hammer blow.Based on that it can only be assumed that the piece of the black composite broke off while the device was hit with an hammer.Product was not returned, therefore no further investigation is possible.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 or material is made available, the investigation will be updated as applicable.Device history lot product code: 03.033.001 lot number: 4l45943 manufacturing site: hägendorf release to warehouse date: aug 30, 2019 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.
 
Event Description
Additional event information the surgery was successfully completed with a backup set.
 
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Brand Name
RADIOLUCENT INSERTION HANDLE
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11179983
MDR Text Key254864207
Report Number8030965-2021-00367
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07612334121776
UDI-Public7612334121776
Combination Product (y/n)N
PMA/PMN Number
K172157
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 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.033.001
Device Lot Number4L45943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Date Manufacturer Received02/25/2021
Patient Sequence Number1
Treatment
DRIVING CAP F/INSERTION HANDLE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAILS
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