MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4MM STERNALOCK (TM) SYSTEM SELF-DRILLING SCREW; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00047, 0001032347-2020-00048, 0001032347-2020-00050.Medical products: sternalock blu system plate, 8 hole straight, part# 73-1952, lot# j143660.Sternalock blu system plate, 8 hole straight, part# 73-1952, lot# 948420.2.4mm sternalock (tm) system self-drilling screw, part# 71-6410, lot# unk.2.4mm sternalock (tm) system self-drilling screw, part# 71-6412, lot# unk.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported that one sternal plate fractured and screws backed out of a plate seven months post-operatively.In (b)(6) 2019, three plates and ten screws were implanted in a ravitch procedure correcting pectus excavatum.In (b)(6) 2019, the implants were removed and replaced with new plates and screws.The patient is reported to be in good condition following the revision surgery.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As there was a revision surgery, the complaint is confirmed.There are no x-rays, scans, or physician's reports available.A visual inspection was conducted and the products show heavy wear.The screws appeared to have damage on the locking threads, which could indicate that they did not get fully locked into the plate during insertion.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.For this part (71-6410) and the previous four years (from the notification date) regarding the screw coming loose post op, there is a complaint rate of 0.38%, which is no greater than the occurrence listed in the application fmea.Because of the lack of information, the most likely underlying cause cannot be determined, though it is possible the screws were not fully inserted and locked into the plate.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 2.4MM STERNALOCK (TM) SYSTEM SELF-DRILLING SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9577866
• Report Number: 0001032347-2020-00049
• Device Sequence Number: 11407638
• Product Code: HRS
• UDI-Device Identifier: 00841036075606
• UDI-Public: 00841036075606
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 71-6410
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 15 YR