MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MED HOWMEDICA BONE PLUG 1PK; CEMENT OBTURATOR

Catalog Number	6215-5-011
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Two separate bone plugs were opened for surgery and deemed unsterile due to seal on packaging.Update 12/jun/2018: spoke to rep.The seal on the outer blister was not adhered to the outer blister all the way around and there were 'gaps' allowing air to pass in and out.The seal on the inner blister was also not adhered to the inner blister all the way around with the same 'gaps'.This happened with 2 devices with 2 different lots.The outer boxes were discarded before the rep could retrieve them.Primary tka procedure.Rep was present in the operating room and witnessed the event.Additional devices were immediately available in the operating room and there was no surgical delay - the surgeon was not even aware of the event until after the procedure was complete.
Additional Manufacturer Narrative
An event regarding pack damage involving a bone plug was reported.The event was confirmed.Conclusions: it was deemed through nc that this event is not manufacturing related.The conclusion of this nc stated [.] there are sufficient controls and inspection steps in the manufacturing process to verify seal integrity and that the shrink wrap meets all workmanship standards.It can be concluded that the seal breaches of the complaint parts did not occur during the manufacturing process, and must have occurred externally.[.] the exact cause of the event could not be determined because insufficient information was provided.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Two separate bone plugs were opened for surgery and deemed unsterile due to seal on packaging.Update 12/jun/2018: spoke to rep.The seal on the outer blister was not adhered to the outer blister all the way around and there were 'gaps' allowing air to pass in and out.The seal on the inner blister was also not adhered to the inner blister all the way around with the same 'gaps'.This happened with 2 devices with 2 different lots.The outer boxes were discarded before the rep could retrieve them.Primary tka procedure.Rep was present in the or and witnessed the event.Additional devices were immediately available in the or and there was no surgical delay - the surgeon was not even aware of the event until after the procedure was complete.

• Brand Name: MED HOWMEDICA BONE PLUG 1PK
• Common Device Name: CEMENT OBTURATOR
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7658868
• Report Number: 0002249697-2018-02030
• Device Sequence Number: 11354045
• Product Code: LZN
• UDI-Device Identifier: 07613327036671
• UDI-Public: 07613327036671
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K951860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 6215-5-011
• Device Lot Number: CPPUE07BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR