MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREWS,CROSS-PIN,SELF-T,1.7X10MM; PLATE, FIXATION, BONE

Model Number 53-17010S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.Therefore, it is subject to reportability under mdr.Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.

Event Description

The report states, " the screw broke off at the head during the surgery.Damaged fragments left in the patient's body.".

Event Description

The report states, " the screw broke off at the head during the surgery.Damaged fragments left in the patient's body.".

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREWS,CROSS-PIN,SELF-T,1.7X10MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13573209
• MDR Text Key: 287124330
• Report Number: 0008031020-2022-00067
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540541123
• UDI-Public: 04546540541123
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53-17010S
• Device Catalogue Number: 53-17010S
• Device Lot Number: 1000427032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1