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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., BOOT-PAIR, HIP DISTRACTOR APPARATUS, TRACTION, NON-POWERED

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STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., BOOT-PAIR, HIP DISTRACTOR APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 3105000801
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 07/02/2018
Event Type  Injury  
Manufacturer Narrative
The device manufacture date is not known at this time. However, should it become available, it will be provided in future reports. Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that post op pain occured as a result of prolonged traction.
 
Manufacturer Narrative
Alleged failure: patient experienced post op pain due to prolonged traction probable root cause: design: boot does not adequately distribute pressure. Boots are not adequately secured. Boas don¿t provide sufficient tactile feedback. No indication of force felt by patient. Process: boa laces routed incorrectly. Use errors. The product was not returned for investigation therefore the reported failure mode was not confirmed. The reported failure mode will be monitored for future reoccurrence. The device manufacture date is not known.
 
Event Description
It was reported that post op pain occured as a result of prolonged traction.
 
Event Description
It was reported that post op pain occured as a result of prolonged traction.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed. Alleged failure: patient experienced post op pain due to prolonged traction. Probable root cause: design: materials bend/dent under force. Design of joints and locking mechanisms. Connectors or locks break under traction force. Casters slip on floor. Boot spine bends. Boot boas unreel due to torque limit. Boa connection guide breaks under high tension. Patient position pad slides on table or patient slides on top of pad. Patient position belt not strong enough to prevent patient from sliding. Use error. The device manufacture date is not known. The reported failure mode will be monitored for future reoccurrence.
 
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Brand NamePKG., ASSY., BOOT-PAIR, HIP DISTRACTOR
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7931389
MDR Text Key122620758
Report Number0002936485-2018-00632
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3105000801
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/03/2018 Patient Sequence Number: 1
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