MAUDE Adverse Event Report: STRYKER GMBH HUMERAL INSERT TRIAL - 3 2MM X 4MM STANDARD; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5901-IS-3204

Device Problem Crack (1135)

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

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "during final trialing of case, humeral insert trialing cracked during reduction.Just a small portion cracked off so no action was needed to support failure of trial.Outcome of the surgery was completed and no harmful circumstances." per email from rep, "trial did crack into two pieces, but both pieces were removed from the patient and surgical field.No delays, final trialing was complete at that point.".

Manufacturer Narrative

The reported event that humeral insert trial - 3 2mm x 4mm standard was alleged of 'instruments - peek - cracks / damage' 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 the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not returned.

Event Description

As reported: "during final trialing of case, humeral insert trialing cracked during reduction.Just a small portion cracked off so no action was needed to support failure of trial.Outcome of the surgery was completed and no harmful circumstances." per email from rep, "trial did crack into two pieces, but both pieces were removed from the patient and surgical field.No delays, final trialing was complete at that point.".

• Brand Name: HUMERAL INSERT TRIAL - 3 2MM X 4MM STANDARD
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7452122
• MDR Text Key: 106387367
• Report Number: 0008031020-2018-00313
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5901-IS-3204
• Device Lot Number: MAC10W09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other