MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANT - CRANIOTOMY GAP WEDGE

Model Number	OP82011
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: distributor returned devices for exchange on 12-oct-2017; the reported non-conformity was confirmed.A review of the manufacturing records showed no anomalies.A review of previous complaint history shows that no similar complaints have been reported.All available devices in inventory manufactured during the same timeframe were visually inspected for unsealed pouches.No additional impacted devices were identified.Potential contributing manufacturing factors have been considered and corrective actions have been initiated.A good faith effort will be made to inspect all remaining inventory for this issue prior to shipment.(b)(4).
Event or Problem Description
On september 27, 2017, it was reported by our contract distributor (b)(4) in (b)(4) that the outer pouch for part craniotomy gap wedges (op82011); lot 00855421005727 018141116 was not sealed.No patient or end user involvement.

• Brand Name: OMNIPORE SURGICAL IMPLANT - CRANIOTOMY GAP WEDGE
• Common Device Name: CRANIOTOMY GAP WEDGE
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all road; suite 120; atlanta GA 30349
• MDR Report Key: 6977258
• Report Number: 3009383407-2017-00002
• Device Sequence Number: 10987946
• Product Code: KKY
• UDI-Device Identifier: 00855421005727
• UDI-Public: 00855421005727
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K123908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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: Other
• Device Expiration Date: 11/01/2021
• Device Model Number: OP82011
• Device Catalogue Number: OP82011
• Device Lot Number: 00855421005727 018141116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1