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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER CAS 3.5MM HEX HEAD SCREW X 38MM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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ZIMMER CAS 3.5MM HEX HEAD SCREW X 38MM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Metal Shedding Debris (1804)
Patient Problems Inflammation (1932); Device Embedded In Tissue or Plaque (3165)
Event Date 04/07/2017
Event Type  Injury  
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Review of the complaint history determined that no further action is required as no trends were identified. Review of the complaint history determined that no further action is required as no trends were identified. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
(b)(4) - date of event - date of initial procedure. Report source, foreign ¿ event occurred in (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during an initial knee arthroplasty procedure, parts of the metal threads of a screw became lodged in the patient's tibia. The patient experienced inflammation, resulting in a procedure to remove the metal shards approximately three months after initial procedure.
 
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Brand Name3.5MM HEX HEAD SCREW X 38MM
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ZIMMER CAS
75 queen str.
suite 3300
montreal, quebec H3C 2 N6
CA H3C 2N6
Manufacturer (Section G)
ZIMMER CAS
75 queen str.
suite 3300
montreal, quebec H3C 2 N6
CA H3C 2N6
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6787349
MDR Text Key109650789
Report Number0009617840-2017-00023
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PK141601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8000-000-18
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1
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