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

Model Number 3105000801

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/22/2020

Event Type  malfunction  

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 Description

It was reported that there were post op sensation issues in the feet.

Event Description

It was reported that there were post op sensation issues in the feet.

Manufacturer Narrative

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 boas 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.Manufacture date is not known.

• Brand Name: PKG., ASSY., BOOT-PAIR, HIP DISTRACTOR
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9694278
• MDR Text Key: 182725239
• Report Number: 0002936485-2020-00061
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 07613327376340
• UDI-Public: 07613327376340
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3105000801
• Device Catalogue Number: 3105000801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1