MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKER POSTFREE FRAME; APPARATUS, TRACTION, NON-POWERED

Catalog Number	3105000100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
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 the hip distractor bed malfunctioned.
Additional Manufacturer Narrative
Based off of previous complaint investigation (b)(4), the failure alleged in the complaint record was confirmed during the product investigation.The product was not received for investigation at stryker endoscopy because it was evaluated by the legal manufacturer, composite manufacturing.The oem investigation report is attached (see communication log), and indicates: reason for rma: replace lower pawl in horizontal spar assembly, 3-2022-286.Pawl would not actuate due to interference.Pawl design was updated to remove interference and replaced on compromised assemblies.Eca 689.Diagnostic codes: r-lbd, a-kms, r-nca description: the bottom pawl, 3-2022-286 was evaluated and confirmed to cause interference and remain in unlocked position under traction.The interference was a known design flaw and an engineering change was instigated by stryker endoscopy previous to this failure.This is the lower pawl that interacts with the aluminum toothed rack, and functions as the brake for gross traction.Pawl was replaced with updated revision b.Various labels were replaced due to damage.Knob assembly in one outer horizontal spar was able to be removed, damage to e-clip retainer was the cause, e-clip retainer was replaced and installed.Unit was packaged incorrectly and tenzor left unlocked during shipping.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that the hip distractor bed malfunctioned.

• Brand Name: STRYKER POSTFREE FRAME
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7639931
• Report Number: 0002936485-2018-00514
• Device Sequence Number: 2481836
• Product Code: HST
• UDI-Device Identifier: 07613327380361
• UDI-Public: 07613327380361
• 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): 02/21/2019

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 Catalogue Number: 3105000100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1