MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE; TEMPORARY FIXATON SCREW

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
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.Concomitant medical products- zimmer biomet traumaone system contra angle cross-drive blade catalog #: sp-2379 lot #: ni; zimmer biomet 90° contra angle driver catalog #: 24-1189 lot #: ni.Multiple mdr reports were filed for this event, please see associated report:0001032347-2019-00289.
Event or Problem Description
It was reported that during an orif of fractured ribs the drivers either stripped or pins became stuck in the drivers.One pin became stuck in the driver during use on the patient's fourth rib and in an attempt to free the pin, the surgeon pulled on the driver causing the temporary pin to pull and strip the patient's bone.No additional patient consequences were reported.
Additional Manufacturer Narrative
Mdr follow up manufacturer¿s narrative (no product return, no dhr, no conclusion) this follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE
• Common Device Name: TEMPORARY FIXATON SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8634373
• Report Number: 0001032347-2019-00290
• Device Sequence Number: 1816080
• Product Code: HRS
• UDI-Device Identifier: 00841036202255
• UDI-Public: 00841036202255
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: 76-0017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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