MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T7, 2.7X14MM; SCREW, FIXATION, BONE

Model Number	53-27614S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be reported in a supplemental report.
Event or Problem Description
The patient complained of pain which found out back out of the screw from the plate.Removal of the screw was scheduled for (b)(6) 2021.There was a possibility that screw was not locking to the plate.
Additional Manufacturer Narrative
The reported event could not be confirmed since no evidence was provided to suggest about the backout happening and also which screw backed out.The device inspection revealed the following: all the 3 received screws of 14mm length showed consistent damage of the locking threads.The damage pattern indicates towards a rather improper insertion.Along with that, the hex of the screws were also found to be severely damaged which may or may not have been caused during explantation.The batch record could not be reviewed because no identification mark was present on the returned screw, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The available information suggests that one screw backed out, but it was not communicated which one and also due to lack of additional information such as medical reports, x-rays etc., it couldn¿t be determined which screw backed out.Through the device inspection it was observed that almost all the returned screws exhibited similar consistent damage pattern along the threads, thus even with device inspection it was not possible to determine that one affected screw and the root cause of the failure.If any further substantial information is provided, the investigation report will be updated.
Event or Problem Description
The patient complained of pain which found out back out of the screw from the plate.Removal of the screw was scheduled for (b)(6) 2021.There was a possibility that screw was not locking to the plate.

• Brand Name: LOCKING SCREW, T7, 2.7X14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11704190
• Report Number: 0008031020-2021-00178
• Device Sequence Number: 3481413
• Product Code: HWC
• UDI-Device Identifier: 04546540593962
• UDI-Public: 04546540593962
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080667
• 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): 06/10/2021

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: Lay User/Patient
• Device Model Number: 53-27614S
• Device Catalogue Number: 53-27614S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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 Age: 70 YR