MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical product ¿ zimmer biomet 1.5mm system high torque (ht), sd, x-dr, screw catalog #: 91-6104 lot #: ni.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).The investigation is in process.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: 0001032347-2019-00351.
Event or Problem Description
It was reported that during a craniotomy, the screws fractured during final tightening and remain in the patient's bone.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.Multiple attempts were made to obtain more information regarding the retention of a foreign body in the patient's bone, but conflicting responses were received.Therefore, zimmer biomet cannot determine if a foreign body was retained in the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint could not be verified as no product was returned and no functional tests or inspections could be performed.The dhr of this product could not be reviewed due to the lot number being unknown.There are no indications of manufacturing defects.For the part #91-6105 and the previous year (from the notification date), there is a complaint rate of 0.06% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint could not be determined.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: 1.5MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW
• Common Device Name: SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8765717
• Report Number: 0001032347-2019-00352
• Device Sequence Number: 2565929
• Product Code: JEY
• UDI-Device Identifier: 00841036053741
• UDI-Public: 00841036053741
• Combination Product (Y/N): N
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 91-6105
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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
• Patient Age: 47 YR