MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.5MM / L20MM; PLATE, FIXATION, BONE

Catalog Number	PLSL3520
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The following event was reported: the head of the locking screw diameter 3.5 mm and length 2 cm went through the anchorage plate catalog# plp50230.Precautionary measure and actions taken by a change of devices.
Additional Manufacturer Narrative
The reported event that locking screw anchorage ø3.5mm / l20mm was alleged of 'poor fixation' could be confirmed.The root cause of this positioning issue has been identified as user related.When too much torque is applied during screw insertion, it can happen that the screw goes through the plate.However, it was identified that under certain circumstances, the screw might slip through the plates.This might lead to prolongation of surgery time (less than 15 minutes) and in rare cases a bone damage due to an unused screw hole can occur.Based on r&d, marketing and vp qa/ra decision and the low risk, confirmed by hcp, no containment was implemented.Moreover, products are conforming to manufacturing specifications and no threashold of the risk management file was exceeded.This was identified as an opportunity for improvment of the design and, thus, a new design of the screw has been implemented in order to increase the torque value which is necessary to bring the locking mechanism to failure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The following event was reported: the head of the locking screw diameter 3.5 mm and length 2 cm went through the anchorage plate catalog# plp50230.Precautionary measure and actions taken by a change of devices.

• Brand Name: LOCKING SCREW ANCHORAGE Ø3.5MM / L20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8256880
• Report Number: 0008031020-2019-00030
• Device Sequence Number: 16664387
• Product Code: HRS
• UDI-Device Identifier: 07613252262398
• UDI-Public: 07613252262398
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: PLSL3520
• Device Lot Number: L44188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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: Other
• Patient Age: 58 YR
• Patient Weight: 64