MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIBIAL STANDARD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64953102

Device Problem Packaging Problem (3007)

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

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

Standard proximal tibia (gmrs) 6495-3-102 was opened in the operating room.The non-sterile outer packaging was removed from the implant box.When peeling open the outer package to expose the inner sterile package, part of the outer plastic package was torn away with the peel away paper top.The inner sterile package appeared to be undamaged.Upon opening the inner sterile package, debris was found in around the proximal tibial implant.The debris appeared to be little white fibers or small particles of the paper seal from the inner sterile package.Questions arose regarding the integrity of the outer packaging and the subsequent sterility of the implant within the inner package.Surgeon decided not to implant the standard proximal tibia.The small proximal gmrs segment was substituted out of necessity.Tourniquet was inflated for 120 minutes, deflated for 20, then reinflated for 30 additional minutes, total tourniquet time 150 minutes.

Manufacturer Narrative

An event regarding packaging damage and associated debris involving gmrs tibial component was reported.The event was confirmed based on review of the returned device.Method & results: device evaluation and results: visual inspection was performed on the returned part and packaging.The outer carton shows signs of damage and indentations associated with excessive handling.The opening flaps are torn and worn in areas.The outer blister has one side of the flange cracked off (it remains attached to the tyvek peel off lid).The inner blister has a white debris (specks) distributed throughout the internal surface.The outline of the gmrs tibial component is indented into the packaging- again associated with excessive handling.The component itself also has evidence of the white debris, apart from this the part is unremarkable.An advanced technology engineer was provided with the gmrs proximal tibia for ftir/atr testing to characterize the white debris.The top match was polyethylene film which showed a 63% match.Normally, the rule of thumb for confidence in the match is above 75%.Thus, the subtracted spectrum was not enough to identify the debris.The reason for this was the nature of the debris appearing to be statically adhered to the inner blister making it difficult to be harvested and tested.This indirect method of testing the blister with some debris on it, does not ensure enough debris material on the atr crystal.This resulted in in-conclusive results.In conclusion, due to the nature and distribution of the foreign debris on the inner blister, the ftir/atr was unable to provide a confident confirmed match for the debris material.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: visual inspection was performed on the returned part and packaging.The outer carton shows signs of damage and indentations associated with excessive handling.The opening flaps are torn and worn in areas.The outer blister has one side of the flange cracked off (it remains attached to the tyvek peel off lid).The inner blister has a white debris (specks) distributed throughout the internal surface.The outline of the gmrs tibial component is indented into the packaging- again associated with excessive handling.The component itself also has evidence of the white debris, apart from this the part is unremarkable.An advanced technology engineer was provided with the gmrs proximal tibia for ftir/atr testing to characterize the white debris.The top match was polyethylene film which showed a 63% match.Normally, the rule of thumb for confidence in the match is above 75%.Thus, the subtracted spectrum was not enough to identify the debris.The reason for this was the nature of the debris appearing to be statically adhered to the inner blister making it difficult to be harvested and tested.This indirect method of testing the blister with some debris on it, does not ensure enough debris material on the atr crystal.This resulted in in-conclusive results.In conclusion, due to the nature and distribution of the foreign debris on the inner blister, the ftir/atr was unable to provide a confident confirmed match for the debris material.While we cannot conclusively identify the white particulate matter, based on the visual inspection of the returned device, it is highly likely that excessive handling /shipping damage of the component has occurred resulting in excessive micromotion and wear of the inner blisterpack generating the white particulate.The carton presents with indentation and compression lines indicating excessive handling/shipping damage.The opening flap is torn and worn.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Standard proximal tibia (gmrs) 6495-3-102 was opened in the operating room.The non-sterile outer packaging was removed from the implant box.When peeling open the outer package to expose the inner sterile package, part of the outer plastic package was torn away with the peel away paper top.The inner sterile package appeared to be undamaged.Upon opening the inner sterile package, debris was found in around the proximal tibial implant.The debris appeared to be little white fibers or small particles of the paper seal from the inner sterile package.Questions arose regarding the integrity of the outer packaging and the subsequent sterility of the implant within the inner package.Surgeon decided not to implant the standard proximal tibia.The small proximal gmrs segment was substituted out of necessity.Tourniquet was inflated for 120 minutes, deflated for 20, then reinflated for 30 additional minutes, total tourniquet time 150 minutes.

• Brand Name: GMRS PROXIMAL TIBIAL STANDARD
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8367785
• MDR Text Key: 137378563
• Report Number: 0002249697-2019-01180
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327048865
• UDI-Public: 07613327048865
• Combination Product (y/n): N
• PMA/PMN Number: K023087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 64953102
• Device Lot Number: 068838R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR