MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation sternalock blade catalog #: 73-1194, lot #: 251810; biomet microfixation sternalock pd blade catalog #: 73-1191, lot #: 263760.Therapy date - unknown.Occupation - sales representative.Initial reporter also sent report to fda: the user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).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: 0001032347-2019-00218 & 0001032347-2019-00219.
Event or Problem Description
It was reported by the sales rep that the small ball on top of the blade broke during a procedure.Attempts have been made and no further information has been provided.
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 blades were returned for investigation.The short blade still had the tip intact, however, the blade was clearly bent.The complaint is confirmed.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due excessive force being applied, possibly during an off-axis attempt to insert a screw.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00218-1 & 0001032347-2019-00219-1.

• Brand Name: STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVE
• Common Device Name: BLADE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8511363
• Report Number: 0001032347-2019-00220
• Device Sequence Number: 16552691
• Product Code: HRS
• UDI-Device Identifier: 00841036140984
• UDI-Public: (01)00841036140984(10)324590
• Combination Product (Y/N): N
• PMA/510(K) Number: K161896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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 Model Number: N/A
• Device Catalogue Number: 73-1191
• Device Lot Number: 324590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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