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

Model Number	3105000801
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there were post op sensation issues in the feet.
Event or Problem Description
It was reported that there were post op sensation issues in the feet.
Additional Manufacturer Narrative
The device manufacturer date is not known.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: post op sensation issues in the feet.Probable root cause: design boa's don't provide sufficient tactile feedback applied torque is not limited no indication of force felt by patient insufficient padding to protect foot boot compresses sensitive anatomy boot liner bunches and/or foam overlaps incorectly to cause pressure point use error.The reported failure mode will be monitored for future re-occurrence.

• Brand Name: PKG., ASSY., BOOT-PAIR, HIP DISTRACTOR
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9694282
• Report Number: 0002936485-2020-00062
• Device Sequence Number: 11439074
• Product Code: HST
• UDI-Device Identifier: 07613327376340
• UDI-Public: 07613327376340
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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 Number: 3105000801
• Device Catalogue Number: 3105000801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1