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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SURGICAL OFFSET DOUBLE CLAMP

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ZIMMER BIOMET SURGICAL OFFSET DOUBLE CLAMP Back to Search Results
Catalog Number 00-1238-004-00
Device Problems Break; Unintended Collision
Event Date 06/25/2015
Event Type  Injury  
Event Description

It was reported that when the patient grabbed the trapeze bar to transfer in bed, the offset double clamp bar broke. The patient was hit by the traction setup and the staff member was hit in the head by the broken airborne clamp, and the hence staff member incurred injury. Additional information received indicated that there was no injury sustained by the patient; however the employee injured in the incident was treated for a concussion by a neurologist. The employee was stated to be recovering and was initially off-work for the injury; however the employee returned to work regular duty as of (b)(6) 2015. No further information regarding the name/identification of the employee or details of the treatment provided to the employee by the neurologist were able to be provided.

 
Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report. A follow up medwatch will be submitted once the investigation is complete.

 
Manufacturer Narrative

The customer's complaint that the offset double clamp bar broke. The photographs provided by the customer confirmed this reported incident. The cause for the clamp to break was a modification of the clamp casting by drilling a second through hole. This second hole weakened the clamp casting. It appears in the photograph that the additional hole was drilled to rotate the location of the clamp jaw. It is not known if the re-drilling was performed by zimmer (b)(4) or superb manufacturing as an unauthorized and/or undocumented rework to correct the clamp location. Additionally, it is not known if the customer drilled the extra hole to modify the clamp location for a specific use. The cause for the component failure was due to the additional through hole. The root cause for the second hole is unknown. However, the current supplier for this product has amended their manufacturing instructions to add a quality caution: "quality concern: if the hole is drilled in the wrong location, do not re-drill the hole. This would cause the bar to be weakened and no longer be incompliance. The bar has to be scrapped out. This applies to all bars with holes drilled through them. ".

 
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Brand NameOFFSET DOUBLE CLAMP
Type of DeviceOFFSET DOUBLE CLAMP
Manufacturer (Section D)
ZIMMER BIOMET SURGICAL
200 west ohio ave
dover OH 44622
Manufacturer (Section G)
ZIMMER BIOMET SURGICAL
200 west ohio ave
dover OH 44622
Manufacturer Contact
kathleen smith
200 w. ohio ave.
dover , OH 44622
3303438801
MDR Report Key4974431
Report Number1526350-2015-00137
Device Sequence Number1
Product CodeILZ
Report Source Manufacturer
Source Type User facility,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00-1238-004-00
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2015
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 Reuse

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