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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AWL; N/A

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ZIMMER SWITZERLAND MANUFACTURING GMBH AWL; N/A Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2021
Event Type  malfunction  
Manufacturer Narrative
This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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.(b)(4).
 
Event Description
During the surgery, the t handle of the device (t handle awl) fractured.However, no pieces fell into the patient and no injury was sustained by the patient.There was no surgical delay.The implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
 
Event Description
No event update.Investigation results are now available.
 
Manufacturer Narrative
Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.Review of event description: it was reported that during a left primary hip surgery, the t-handle of the cls awl fractured.No pieces fell into the patient and there was neither surgical delay nor any patient impact.Review of received data: - no medical data relevant to the case has been received.However, one image of low resolution of the fractured device has been received.It can merely be seen that the handle of the cls awl is detached from the schaft, possibly at the weld-site.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that during a left primary hip surgery, the t-handle of the cls awl fractured.No pieces fell into the patient and there was neither surgical delay nor any patient impact.The investigation did not identify a nonconformance or a complaint out of box (coob).No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the part is unknown.However, one image of low resolution of the fracture device has been received.It can merely be seen that the handle of the cls awl is detached from the schaft, possibly at the weld-site.Based on the investigation the reported event can be confirmed.The reported product has been manufactured in the year 2004, which might have contributed to its fracture due to possible material fatigue at our around the weld-site.However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
 
Manufacturer Narrative
This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Additional information was received on aug 18, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received the device on aug 18, 2021.The investigation of the case is still ongoing.Should additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
 
Event Description
Event happened during a left hip surgery.During the surgery, the handle of the device fractured.
 
Manufacturer Narrative
This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Investigation results were made available.Additional: d10, h2, h6.Correction: b4, b5, d9, g3, g6, h3, h10.1.Event description: it was reported that during a left primary hip surgery, the t-handle of the cls awl fractured.No pieces fell into the patient and there was neither surgical delay nor any patient impact.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.However, one image of low resolution of the fractured device has been received.It can merely be seen that the handle of the cls awl is detached from the shaft, possibly at the weld-site.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Product evaluation: - the device was returned for examination.The handle fractured at the welding.The material at the fracture surface is brownish discolored and shows signs of corrosion.See images attached.4.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.5.Conclusion: it was reported that during a left primary hip surgery, the t-handle of the cls awl fractured.No pieces fell into the patient and there was neither surgical delay nor any patient impact.The investigation did not identify a non-conformance or a complaint out of box (coob).Based on the visual examination the reported event can be confirmed.The reported product has been manufactured in the year 2004, hence recurrent usage (loading of the device), cleaning and sterilization may have caused or contributed to the reported event.Nevertheless, based on the given information and the results of the investigation, a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer¿s reference number of this file is (b)(4).
 
Event Description
Product was received, investigation has been updated.
 
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Brand Name
AWL
Type of Device
N/A
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
MDR Report Key11320492
MDR Text Key233045959
Report Number0009613350-2021-00081
Device Sequence Number1
Product Code HWJ
UDI-Device Identifier00889024301788
UDI-Public00889024301788
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/30/2021
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 Number70.08.89
Device Lot Number04127249
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/14/2021
Initial Date FDA Received02/12/2021
Supplement Dates Manufacturer Received06/16/2021
08/18/2021
09/15/2021
Supplement Dates FDA Received06/22/2021
09/03/2021
09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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