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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AFFIXUS PR HUM TAR GD CNCT BLT; TRAUMA INSTRUMENT

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ZIMMER SWITZERLAND MANUFACTURING GMBH AFFIXUS PR HUM TAR GD CNCT BLT; TRAUMA INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
Medical product: humerus impaction head; catalog#: 110035647; lot#: unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
It was reported that the attachment for the insertion handle (the thread) jammed.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d1 investigation results are now available investigation and conclusion 1.Event description: it was reported that during surgery on (b)(6), 2021 whereby an affixus ph nail was being explanted, the attachment for the insertion handle (the thread) jammed in the thread and a cold weld occurred and could not be removed.However, the nail could be explanted and there was no impact to the patient.Harm: s1 - no patient, user, or other stakeholder harm hazardous situation: instrument breaks, diverges or becomes damaged and non-functional during surgical procedure.2.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: the dhr review could not be performed due to missing product identification.Surgical technique: the surgical technique was reviewed and the nail assembly and insertion are covered starting on page 14/40, whereby the following is stated: assemble the connecting bolt through the guide barrel grip and mate to the desired nail implant.The utilization of the impaction head with the slotted mallet to drive the nail to the desired depth is explained on the following page.Additionally, extraction of the nail is covered on page 27/40, whereby the following is stated: attach the extraction adapter (ref.(b)(4)) to the proximal end of the nail implant.And then attach the slaphammer to the extraction bolt.Backslap on the nail until fully extracted.5.Conclusion: it was reported that during surgery on (b)(6) 2021 whereby an affixus ph nail was being explanted, the attachment for the insertion handle (the thread) jammed in the thread and a cold weld occurred and could not be removed.However, the nail could be explanted and there was no impact to the patient.Due to significant lack of information and missing lot number, a detailed investigation such as in the form of a review of the device manufacturing records could not be performed.Nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Due to the vaguely reported event, in particular the attachment for the insertion handle (the thread) jammed in the thread it is assumed that this is referring to the nail to connection bolt interface.Why the impaction head is listed on the product experience report (per) and its involvement is unknown.However, all the listed products in this complaint (connection bolt, targeting guide barrel grip, impaction head) are devices used during implantation of the affixus nail, as per surgical technique.According to the surgical technique, the recommended approach is to use the extraction adapter and attaching a slaphammer to the extraction bolt for extraction.If a deviation from the recommended surgical approach was performed however remains unknown as the clear nature and details of the event are unknown.Additionally, neither devices nor photos of the devices were received; therefore the condition of the components is unknown.Hence the reported event cannot be confirmed.Based on the given information and the results of the investigation, we were neither able to confirm the reported event nor identify a specific root cause for this issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet's reference number of this file is (b)(4).
 
Event Description
Investigation results are now available.
 
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Brand Name
AFFIXUS PR HUM TAR GD CNCT BLT
Type of Device
TRAUMA INSTRUMENT
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ   8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12743987
MDR Text Key281742985
Report Number0009613350-2021-00554
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00889024506633
UDI-Public00889024506633
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/03/2022
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 NumberN/A
Device Catalogue Number110035672
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/04/2021
Initial Date FDA Received11/03/2021
Supplement Dates Manufacturer Received02/24/2022
Supplement Dates FDA Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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