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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ZIMMER JOINT CAPSULE SCISSORS

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ZIMMER GMBH ZIMMER JOINT CAPSULE SCISSORS Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2017
Event Type  malfunction  
Manufacturer Narrative
Trend analysis: no trend considering the following event is identified: instrument fracture. Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended. Event summary: it was reported that one tip of the joint capsule scissors has fractured during surgery. No harm to patient. No medical data such as surgical notes or any other case-relevant documents received. Devices analysis visual examination: the instrument was returned for an investigation. The tip of one blade has broken off. Moreover there are some small signs of usage visible, e. G. Small scratches. No other conspicuousness found. Review of product documentation clinical evaluation report: it is described that the joint-capsule scissors is intended to cut soft tissues. Root cause analysis: root cause determination using rmw: instrument breaks, deforms, diverges impairing its function due to inadequate design for intended performance not possible a systematic issue with design properties would have been detected as part of the issue evaluation assessment. Instrument breaks, deforms, diverges impairing its function due to mechanical properties of material insufficient not possible a systematic issue with material properties would have been detected as part of the issue evaluation assessment. Fracture of instrument due to general corrosion (crevice, pitting, galvanic) not possible visual examination did not show any signs of corrosion. Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling possible, as it cannot be excluded based on the available information. Moreover, this product might have been on the market for more than 7 years and therefore used excessively. Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling possible, as it cannot be excluded based on the available information. In order for the scissors to break, excessive force must have been applied. Instrument breaks or deforms due to off-label / abnormal-use
=
> possible, as it cannot be excluded based on the available information. In order for the scissors to break, excessive force must have been applied. Conclusion summary the instrument was returned for an investigation. It was manufactured in 2009 and might have been on the market for more than 7 years and therefore used excessively. The scissors are intended to be used for cutting soft tissue only. If the instrument is applied correctly, no large forces should occur. One possible root cause might be, that the instrument was used off-label or it fell to the ground and broke as a results of unexpected high forces. However, based on the available information an exact root cause could not be determined. The need for corrective measures is not indicated and zimmer gmbh considers this case as closed. Zimmer¿s reference number of this file is (b)(4).
 
Manufacturer Narrative
The manufacturer receive the devices and the investigation is ongoing. A picture was received where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. Additional information was requested and received on april 12, 2017. Should additional information become available and 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
It was reported that the surgeon used the zimmer joint capsule scissors and during the surgery the tip of one side of the scissors broke. No pieces were left in the patient. Note: 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.
 
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Brand NameZIMMER JOINT CAPSULE SCISSORS
Type of DeviceZIMMER JOINT CAPSULE SCISSORS
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
kevin escapule
1800 west center street
warsaw, IN 46580
8006136131
MDR Report Key6525278
MDR Text Key254243013
Report Number0009613350-2017-00550
Device Sequence Number1
Product Code HRR
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number75.00.42
Device Lot Number09.464738
Other Device ID Number00889024302389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/27/2017 Patient Sequence Number: 1
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