MAUDE Adverse Event Report: SMITH & NEPHEW, INC. P-L VLP 3.5MM L-P TIBIA LK PL 6H L 93MM; PLATE, FIXATION, BONE

Catalog Number	72800306
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery there was a delay of 40 min due to no physical device once the package was opened.
Additional Manufacturer Narrative
The associated device/packaging was not returned for evaluation.A review of manufacturing records did not reveal any deviations that could have contributed to this issue; the plate was packaged in two sealed pouches within a carton/box.A review of complaint history revealed that we have not had any previous complaints for this device/failure mode.No harm to the patient was reported, other than the extended surgery time.No additional information has been received to verify or aide in our investigation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information be received, the complaint will be reopened.

• Brand Name: P-L VLP 3.5MM L-P TIBIA LK PL 6H L 93MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7025803
• Report Number: 1020279-2017-01010
• Device Sequence Number: 10994733
• Product Code: HRS
• UDI-Device Identifier: 03596010603050
• UDI-Public: 03596010603050
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2026
• Device Catalogue Number: 72800306
• Device Lot Number: 16KM01085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 05/10/2018
• 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: Hospitalization
• Patient Age: 51 YR
• Patient Weight: 78