MAUDE Adverse Event Report: STRYKER GMBH STANDARD BARREL HIP PLATE, KEYLESS OMEGA 3 140°, 4 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	597144S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
Patient in (b)(6) 2018 had a hip fracture and had an omega plate/lag screw as well 7.2 cannulated screw.Hardware was removed prior to starting tha procedure.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Based on the given information, the root cause was attributed to be patient related.The failure was caused due to the mentioned poor bone quality which resulted in the fracture of the acetabulum during the tha procedure.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities, due to the fact as during tha procedure, surgeon was impacting the cup and fractured the acetabulum.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Patient in (b)(6) 2018 had a hip fracture and had an omega plate/lag screw as well 7.2 cannulated screw.Hardware was removed prior to starting tha procedure.As reported in (b)(4): "during tha procedure, surgeon was impacting the cup and fractured the acetabulum.Surgeon pointed out that the bone quality was poor.Registration was 0.2.Patient in (b)(6) 2018 had a hip fracture and had an omega plate/lag screw as well 7.2 cannulated screw.Hardware was removed prior to starting the hip procedure.While fixing the acetabulum he had a hard time get the screws fixated.Case was completed robotically.Surgical delay - 1 hr while placing plate and screw".

• Brand Name: STANDARD BARREL HIP PLATE, KEYLESS OMEGA 3 140°, 4 HOLES
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8784565
• Report Number: 0008031020-2019-00825
• Device Sequence Number: 16743767
• Product Code: KTT
• UDI-Device Identifier: 07613154325566
• UDI-Public: 07613154325566
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K062066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 597144S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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: Required Intervention
• Patient Weight: 71