MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.

Catalog Number	2030-6530-1
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Surgeon complained the two torx screws appeared to not be behaving as expected when using them.The screws reportedly were not progressing into the bone as the threads seemed to be affected.
Event or Problem Description
Surgeon complained the two torx screws appeared to not be behaving as expected when using them.The screws reportedly were not progressing into the bone as the threads seemed to be affected.
Additional Manufacturer Narrative
An event regarding thread damage involving an other hip screw was reported.The event was confirmed based on the device evaluation.Conclusions: it was reported that the bone screws were not advancing into the bone as expected and that the threads seemed to be affected.Evaluation of the returned device indicated that damage was observed on screw consistent with potential cross threading and attempted implantation and explantation.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Therefore event of screw damage was confirmed but root cause could not be determined.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Common Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7788731
• Report Number: 0002249697-2018-02553
• Device Sequence Number: 19417373
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: DD193R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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