MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 6 RIGHT; KNEE FEMORAL COMPONENT

Catalog Number	02.09.2606R
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 august 2017.Lot 155543: (b)(4) items manufactured and released on 01 december 2015.Expiration date: 2020-11-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional information received on 18 august 2017 and includes: the patient was under anesthesia when the event was detected.No other implant option would be available for a gmk-hinge femoral component.The packaging will be returned to medacta international for investigation.
Event or Problem Description
During final implant assembly, a double puncture was found in the packaging of the size 6 right gmk-hinge femoral component.Both the internal and external plastic pill were cracked.The tyvek was not compromised.The sterility was compromised.The implant was rewashed and then autoclaved.The total time delay was in excess of 3 hours.The case was completed successfully.
Additional Manufacturer Narrative
Device packaging only received on 25 august 2017.On 07 september 2017 the packaging and cleaning manager performed a visual inspection of the retrieved packaging and commented as follows: both the outer and the inner blister containing the involved femoral component were found cracked during surgery.Moreover, also the carton box shows signs of damage that could be correlated to the ones found on the two blisters (same position).According to internal procedures, the operator involved in the manufacturing process must 100% check the integrity of the whole packaging of each single item of the lot.Considering that it is indicated that the claimed piece was not released with such damage by medacta international sa, the two following root causes could be evaluated: non-conforming shipping modality.Considering the extent of the breakage, it can be reasonably excluded that the claimed damage could have been generated following the validated shipping instructions.Poor handling of the product.It can't be excluded that during shipment/storage in the hospital the blister could have been accidentally damaged.For all the above, the most probable root cause could be found in an accidental handling damage occurred after the pulling out of the blister from the carton box.On 08 september 2017 the technical director involved in the issue, confirmed that the event was not due to any packaging defect, but more probably to an handling damage.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 6 RIGHT
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6803629
• Report Number: 3005180920-2017-00458
• Device Sequence Number: 969024
• Product Code: KRO
• UDI-Device Identifier: 07630030825507
• UDI-Public: 07630030825507
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: 11/03/2010
• Device Catalogue Number: 02.09.2606R
• Device Lot Number: 155543
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/19/2017
• 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: 61 YR