MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM PRXHUM LK PL 3H R 89MM; PLATE, FIXATION, BONE

Catalog Number	71821303
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a delay from about 1 hour happened during a surgery due to the plate on proximal humerus and locking screws would not lock into plate.Surgeon opted to switch to 3.5 x 5 hole plate instead and screws locked into plate.
Additional Manufacturer Narrative
The associated peri-loc 3.5 mm proximal humerus locking plate was returned and evaluated.A visual inspection of the returned product indicated minor surface damage from attempted use.A functional evaluation of the plate indicated that a mating screw was able to lock into all the plate holes.A dimensional inspection was performed; one hole was unable to get an accurate measurement, due to the deformation potentially from the surgeon's attempt or the functional tests.Our clinical evaluation indicated there was an approximate 1 hour surgical delay which resulted in no patient injury or harm.The procedure was reportedly completed with a 5-hole humeral locking plate without further complication.The patient's current status remains unknown.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.Lot number added.

• Brand Name: 3.5MM PRXHUM LK PL 3H R 89MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7609492
• Report Number: 1020279-2018-01149
• Device Sequence Number: 157045
• Product Code: HRS
• UDI-Device Identifier: 00885556041604
• UDI-Public: 00885556041604
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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 Catalogue Number: 71821303
• Device Lot Number: 18AM13212
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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: Other