MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 3 HOLE / L86MM; PLATE, FIXATION, BONE

Catalog Number 627203

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A non-conformity report had been opened in order to further investigate and address this issue for further details.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.

Event Description

Customer noticed, that the threads of attachment of the rotator cuff in the proximal humerus, which are pulled through the plates, rupture.It is an axsos3 proximal humeral plate.Unfortunately, there is no specific information as to which plate is used.No specific event known.General complaint.It may affect the following items: from 627203 to 627250s.Sales rep confirmed that surgeon uses arthrex threads.

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 3 HOLE / L86MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9159302
• MDR Text Key: 193305901
• Report Number: 0008031020-2019-01357
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327091069
• UDI-Public: 07613327091069
• Combination Product (y/n): N
• PMA/PMN Number: K143138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 627203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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