MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNI ADAPTOR SLEEVE V40 TI; IMPLANT

Catalog Number 6519-T-100

Device Problems Sticking (1597); Packaging Problem (3007)

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

Event Date 03/11/2014

Event Type  malfunction  

Event Description

It was reported that the packaging containers were stuck together.

Manufacturer Narrative

It was noted that the device was implanted but the packaging would be returned for evaluation of the reported event.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding the foam packaging being stuck to the inner blister tyvek lid involving a femoral head adaptor sleeve was reported.The event was confirmed.Visual evaluation of the returned device packaging confirmed that inner blister tyvek lid was attached to the cylindrical packaging foam from the void-filling and heat sealing process.A review of medical records was not performed as none were provided.No further information was requested as there is no indication that the event was related to patient factors.A device history review indicated that all devices that were accepted into final stock conformed to specification.A complaint history review indicated that there have been no similar events for the reported lot.The investigation concluded that foam packaging being stuck to the inner blister tyvek lid of a femoral head adaptor sleeve was caused by a known packaging issue.The raised foam during the sealing operation allowed for excessive contact of the sealing tool with the inner lidstock and packaging foam resulting in sealing or melting of the lidstock to the foam.It is related to a void-filling approach to sterile product packaging.

Event Description

It was reported that the packaging containers were stuck together.

• Brand Name: UNI ADAPTOR SLEEVE V40 TI
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3730507
• MDR Text Key: 17567929
• Report Number: 0002249697-2014-01061
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

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: 02/28/2019
• Device Catalogue Number: 6519-T-100
• Device Lot Number: 46897002
• Other Device ID Number: STER. LOT 1402ICM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 04/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2014
• 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
• Patient Age: 74 YR
• Patient Weight: 98