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

Catalog Number	3105000801
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that post op pain occured as a result of prolonged traction.
Additional 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 or Problem Description
It was reported that post op pain occured as a result of prolonged traction.
Event or Problem Description
It was reported that post op pain occured as a result of prolonged traction.
Additional 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.

• 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: 7931389
• Report Number: 0002936485-2018-00632
• Device Sequence Number: 1798145
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 3105000801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/11/2018; 09/11/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 03/22/2019; 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other