MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 4 HOLE / L99MM; PLATE, FIXATION, BONE

Model Number 627204S

Device Problem Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "event details: when fixing the screw to the plate, it was confirmed that there was metal lint.Physician's point of view: the screws were inserted at a difficult angle, so the metals rubbed against each other and were scraped.".

Event Description

As reported: "event details: when fixing the screw to the plate, it was confirmed that there was metal lint.Physician's point of view: the screws were inserted at a difficult angle, so the metals rubbed against each other and were scraped.".

Manufacturer Narrative

Correction: sections d9, h3.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was 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 device inspection was not possible since the affected device was not returned.However, a circular metalic wire was returned, probably from the screw thread that makes the locking mechanism of the screw.The wire was considered to be a result of the screw and not the plate, since the length received is too long to be a result of the locking mechanism of the plate.The debris was most probably generated as a result of an inadequate angulation of the screw, which lead to the two metals of the plate and screw scratching against each other.The debris could not have resulted from manufacturing, since the devices are inspected before packing.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.H3 other text : device was implanted.

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 4 HOLE / L99MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10339750
• MDR Text Key: 200873947
• Report Number: 0008031020-2020-01988
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327091106
• UDI-Public: 07613327091106
• Combination Product (y/n): N
• PMA/PMN Number: K200398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

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
• Device Operator: Health Professional
• Device Model Number: 627204S
• Device Catalogue Number: 627204S
• Device Lot Number: G14010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR