MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 16MM TITANIUM; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: biomet microfixation screw catalog #: 73-2418 lot #: ni; biomet microfixation sternalock 360 catalog # 74-0004 lot#: ni.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: foreign country: (b)(6).Reported event was confirmed by review of photos provided of the revision surgery.The parts were not returned and therefore could not be visually evaluated or functionally tested.It was reported the patient had a coughing fit, which caused the sternalock 360 band to cut through the sternum.Subsequently, the surgeon had to remove the sternalock 360 and re-wire the sternum.Because there was a revision surgery, the complaint is considered confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to patient condition.A summary of the investigation has been sent to the complainant.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.
Event or Problem Description
It was reported the sternalock 360 band cut through the sternum in two places due to the patient having a coughing fit.The surgeon removed the sternalock 360 and rewired the sternum.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

• Brand Name: STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 16MM TITANIUM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8555108
• Report Number: 0001032347-2019-00249
• Device Sequence Number: 11370288
• Product Code: HRS
• UDI-Device Identifier: 00841036141165
• UDI-Public: 00841036141165
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/26/2019
• 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