MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUP DIST CLAV LK PL L 109MM; PLATE, FIXATION, BONE

Catalog Number	71823403
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a fracture on a plate.
Additional Manufacturer Narrative
The affected peri-loc superior distal clavicle plate along with six screws were returned and evaluated.From the analysis conducted during this investigation, the lab analysis concluded that the plate fractured 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.No material deviations in the locking plate were found during this investigation.A clinical evaluation noted the radiographic images provided confirm the broken plate as well the deformity of the clavicle beneath the plate.A non-union cannot be ruled out based on the limited quality of the provided images.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.No further investigation 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.We consider this investigation closed.

• Brand Name: SUP DIST CLAV LK PL L 109MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7452711
• Report Number: 1020279-2018-00800
• Device Sequence Number: 107271
• Product Code: HRS
• UDI-Device Identifier: 00885556042120
• UDI-Public: 00885556042120
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K061352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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 Catalogue Number: 71823403
• Device Lot Number: 16HM00483
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAT #: 73824012LOT #: 17CM17980; CAT #: 73824014LOT #: 11HM03402; CAT #: 73824014LOT #: 16EM21773; CAT #: 73824014LOT #: 17BM09014; CAT #: UNK (4)LOT #: UNK (4 )
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 22 YR