MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 STERNAL CLOSURE SYSTEM; STERNAL FIXATION DEVICE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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.Report source; (b)(6).
Event or Problem Description
It was reported that while trying to close the patient's chest using sternalock 360 the band snapped while performing the approximation using the tensioner.Surgery was delayed by 10 minutes to open a new package to close the chest.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
This follow-up report is being submitted to relay additional and/or corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.Visual inspection showed that the metal band had been fed up through the tensioner and locked in place, and snapped at the base of the tower.The plate was also slightly discolored and appeared to have been in contact with a patient's blood.The dhr for this product was reviewed; no non-conformances were found.There are no indications of manufacturing defects.For this part (74-0004) and the previous one year (from the notification date) regarding the band snapping, there is a complaint rate of 0.05% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is excessive force was applied during rotation of the tightening wheel to achieve final approximation, beyond what the product was designed to encounter.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.The incorrect lot number was initially provided by the customer and reported in the initial medwatch report.The correct lot number was discovered upon investigation of the received device.Therefore, the lot number, expiration date, and date of manufacture are corrected in this report.

• Brand Name: STERNALOCK 360 STERNAL CLOSURE SYSTEM
• Common Device Name: STERNAL FIXATION DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9823187
• Report Number: 0001032347-2020-00159
• Device Sequence Number: 19289672
• Product Code: HRS
• UDI-Device Identifier: 00841036190668
• UDI-Public: 00841036190668
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2024
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 743810
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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
• Patient Age: 61 YR
• Patient Weight: 85