MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 18MM TITANIUM

Model Number	N/A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical product - biomet microfixation plat,e catalog #: 73-1952, lot #: unk; biomet microfixation screw, catalog #: 73-2416, lot #: unk; biomet microfixation screw, catalog #: 73-2418, lot #: unk; biomet microfixation plate, catalog #: 73-2634, lot #: unk; biomet microfixation screw, catalog #: 73-2714, lot #: unk; biomet microfixation screw, catalog #: 73-2716, lot #: unk; biomet microfixation screw, catalog #: 73-2718, lot #: unk; biomet microfixation screw, catalog #: 73-2720, lot #: unk.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision to remove three screws because they backed out of the plate.The distributor reported that during the patient's follow-up visit with the surgeon, it was noted that the screws backed out.The patient's chest will still open, therefore the surgeon removed the three screws during the office visit.The rest of the plates remain implanted.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.Complaint sample was evaluated and the reported event was confirmed.The three screws were returned for investigation.It was reported that the screws were implanted on 31 jan 2019 and were explanted on 27 mar 2019 because they had backed out of the plate.It was also reported that the patient had poor bone quality and a history of mrsa infection, shingles, and pseudomonas prior to the sternalock devices being implanted.There are no x-rays, scans, or physician's reports available.The screws appeared to have minimal damage on the locking threads, which could indicate that they did not get fully locked into the plate during insertion.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 18MM TITANIUM
• Common Device Name: SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8529251
• Report Number: 0001032347-2019-00240
• Device Sequence Number: 13944546
• Product Code: HRS
• UDI-Device Identifier: 00841036147587
• UDI-Public: 00841036147587
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 73-2418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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: Required Intervention