MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM PRXHUM LK PL 11H L 191MM; PLATE, FIXATION, BONE

Catalog Number	71801411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plate was inserted on (b)(6) 2018.Patient recently had a fall and (possibly) consequently the plate was discovered to be broken.Surgeon believes the plate broke during the fall and this should not happen.Broken plate was removed and replaced with a nail.
Additional Manufacturer Narrative
The associated peri-loc 4.5 mm proximal humerus locking plate was returned and evaluated.A lab analysis conducted during this investigation indicated that the product fractured through the sixth and twelfth hole of the plate.The fracture occured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the locking plate could not bear the imposed patient loading, which lead to an overload fracture.Fatigue cracking is caused by the plate bearing cyclic (i.E.Repeated) stresses in excess of the material endurance limit for an extended period of time.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to: excessive patient activity levels prior to full bone union, applications of loads in excess of the material¿s strength, and/or poor bone quality.An edxa analysis showed no material deviations in the locking plate were found during this investigation.It was reported that the surgeon believes the plate broke during the patient fall.A clinical evaluation noted that the impact to the patient beyond the revision cannot be determined.No further clinical assessment is warranted at this time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: 3.5MM PRXHUM LK PL 11H L 191MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8371667
• Report Number: 1020279-2019-00832
• Device Sequence Number: 1332428
• Product Code: HRS
• UDI-Device Identifier: 03596010573667
• UDI-Public: 03596010573667
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 06/08/2019
• Device Catalogue Number: 71801411
• Device Lot Number: 14FM05740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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; Required Intervention