MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X110.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	6118127110
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that there was a pin hole in the packaging.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
The reported product involved with this event was returned for evaluation and the reported failure of product packaging compromised was confirmed.The product was evaluated by the product packaging engineer who concluded that it is likely that this damage occurred during the distribution (including handling) or storage of the product.The handling may have been more aggressive than expected or an unexpected event occurred.The device has been packaged correctly in its qualified configuration.
Event or Problem Description
It was reported that there was a pin hole in the packaging.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X110.0MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9653981
• Report Number: 0001811755-2020-00368
• Device Sequence Number: 19259690
• Product Code: GFA
• UDI-Device Identifier: 04546540593382
• UDI-Public: 04546540593382
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 03/30/2020

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: Other
• Device Expiration Date: 03/01/2024
• Device Model Number: 6118127110
• Device Catalogue Number: 6118127110
• Device Lot Number: 19064017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1