MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM; PLATE, FIXATION, BONE

Model Number	626675S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The following was reported: "(b)(6) yom had left radial and ulnar shaft fractures after falling from a bicycle and had open reduction and internal fixation (b)(6) 2020.Immediate post-op x-ray showed a straight plate.At 2 week follow-up there was angulation at the radial fracture site.Patient taken to surgery for revision of fixation left radius and ulna and a short arm case applied.When removed during surgery, the plate was found to be bent through the central portion, no loosening of screws.All screws had great purchase." "discharge instructions after first surgery: keep well-padded short arm cast clean and dry at all times.Elevate for a few days for swelling.Wear sling when out of bed.General pediatric discharge education includes no bicycle, skateboard, scooter, etc.For next 24 hours." "at two week check-up, patient doing well, no pain in the cast.Patient denies any falls, cast is somewhat loose.When cast removed there was clinical deformity of the apex dorsal.No signs of infection; incisions were fully healed.X-ray revealed a 10 degree angulation both of the plate and the bone." "no past medical history.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the device was returned and matches the reported event: the plate is indeed bent at the level of the 3rd hole.Around this hole, multiple marks of some sharp instrument have been made.This could possibly be due to a bending of a plate using the plate benders.No marks can be noticed at the level of other holes.More detailed information about the complaint event such as x-rays and patient activity level must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The following was reported: "15 yom had left radial and ulnar shaft fractures after falling from a bicycle and had open reduction and internal fixation (b)(6) 2020.Immediate post-op x-ray showed a straight plate.At 2 week follow-up there was angulation at the radial fracture site.Patient taken to surgery for revision of fixation left radius and ulna and a short arm case applied.When removed during surgery, the plate was found to be bent through the central portion, no loosening of screws.All screws had great purchase." "discharge instructions after first surgery: keep well-padded short arm cast clean and dry at all times.Elevate for a few days for swelling.Wear sling when out of bed.General pediatric discharge education includes no bicycle, skateboard, scooter, etc.For next 24 hours." "at two week check-up, patient doing well, no pain in the cast.Patient denies any falls, cast is somewhat loose.When cast removed there was clinical deformity of the apex dorsal.No signs of infection; incisions were fully healed.X-ray revealed a 10 degree angulation both of the plate and the bone." "no past medical history.".

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10434722
• Report Number: 0008031020-2020-02186
• Device Sequence Number: 2814175
• Product Code: HRS
• UDI-Device Identifier: 07613327088649
• UDI-Public: 07613327088649
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 626675S
• Device Catalogue Number: 626675S
• Device Lot Number: D13751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: Required Intervention
• Patient Age: 15 YR
• Patient Weight: 104