MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX TOBRAMYCIN 1 PK; BONE CEMENT

Catalog Number 61971001

Device Problem Use of Device Problem (1670)

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

Event Date 08/08/2018

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.Review of the device history records indicate packs were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one other similar event for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Customer reported that they have had an issue with two batches of simplex tobramycin cement.During one list, they did four thr with batch/lot number tez018 (8 mixes) and the cement was completely going off at around 7-7:40 minutes.The cement from lot tfz018 was used again on (b)(6) 2018, and the cement had gone off in 3 minutes.Customer said the cement is stored in their cement cupboard at under 25 degrees ( have a thermometer in the cupboard), and they have been using the same mixing method for the cement.Customer is still using the palamix cement mixers (following the supply issues stryker had), using the method of powder, liquid, powder, liquid (as two lots of powder do not fit in the palamix system), starting the clock when the first liquid is added.They previously have not had any issues when using this method until recently.*** update 31aug18 ** customer responded: cement sets too quickly.

• Brand Name: SIMPLEX TOBRAMYCIN 1 PK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7884646
• MDR Text Key: 120700108
• Report Number: 0002249697-2018-02914
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2018

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 61971001
• Device Lot Number: TEZ018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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
• Patient Outcome(s): Other