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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PENCIL BATTERY PACK; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO PENCIL BATTERY PACK; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 1900013000
Medical Device Problem Code Device Remains Activated (1525)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/20/2020
Type of Reportable Event Malfunction
Event or Problem Description
The device overheated during a service evaluation at the manufacturer facility. there were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Additional information: d9 correction: b5 device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device had run on during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
PENCIL BATTERY PACK
Common Device Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10804947
Report Number0001811755-2020-03078
Device Sequence Number11617847
Product Code HWE
UDI-Device Identifier07613327071986
UDI-Public07613327071986
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
E527860
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/17/2021
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
Operator of Device Health Professional
Device Model Number1900013000
Device Catalogue Number1900013000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Initial Date Received by Manufacturer 10/20/2020
Supplement Date Received by Manufacturer06/17/2021
Initial Report FDA Received Date11/06/2020
Supplement Report FDA Received Date06/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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