MAUDE Adverse Event Report: ENCORE MEDICAL L.P. CANCELLOUS BONE SCREW; SCREW, CANCELLOUS, 25MM

Catalog Number	010-55-025
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Left in patient.
Event or Problem Description
Primary surgery - the acetabular screw post-operatively was screwed through the screw hole.This was determined on the post-op x-ray.
Additional Manufacturer Narrative
The reason for this complaint was to report the acetabular screw post-operatively was screwed through the screw hole.This was determined on the post-op x-ray.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery.The revision surgery was completed as intended.The device was left in the patient and not made available to djo surgical for examination.A review of the device history records (dhr), shows that the reported items met design and manufacturing requirements.There were no ncmrs associated with the item and its applicable concomitant item that may have contributed to reported event.There were no findings during this investigation that indicate that the reported items were the source of the reported event.The root cause of this complaint is as reported "acetabular screw post-operatively was screwed through the screw hole".Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.
Additional Manufacturer Narrative
Additional information received: a search of the complaint database for similar events found four (4) similar events where the screw went through an acetabular shell.The events occurred in 2003 ((b)(4)), 2006 ((b)(4)), 2007((b)(4)) and 2008 ((b)(4)).In the case of (b)(4) it was determined that the shell had been inadvertently contacted by the drill during surgery changing the hole size and shape allowing the screw to pass through.Laboratory testing, of the parts received for (b)(4), showed that an unusually high torque would be required to push a screw through a shell.The cancellous screw is installed by hand instrumentation which cannot produce the amount of force needed to push the screw through the shell.Powered screw drivers should not be used for the placement of screws in the acetabular shell.(b)(4).

• Brand Name: CANCELLOUS BONE SCREW
• Common Device Name: SCREW, CANCELLOUS, 25MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6201434
• Report Number: 1644408-2016-01025
• Device Sequence Number: 16332734
• Product Code: HWC
• UDI-Device Identifier: 00888912069977
• UDI-Public: (01)00888912069977
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K931665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2017

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: Health Professional
• Device Expiration Date: 10/25/2022
• Device Catalogue Number: 010-55-025
• Device Lot Number: 006A1265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 03/15/2017; 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 430-93-060,LOT 046H1019
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR