MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORGUE (HT), SD, X-DR, SCR, 5/PK; ORTHOPEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2020
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: unknown screw, catalog number ni.Lot number ni.Report source: (b)(6).
Event or Problem Description
It was reported that while attempting to insert a screw, the screw fractured halfway into the bone.The fractured portion of the screw was not removed and remained in the bone.
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.The complaint is confirmed.A visual inspection was conducted on the screws and each show heavy wear.The screws have each fractured where the screw head meets the screw body.The dhr was reviewed and there were no nonconformances found.There are no indications of manufacturing defects.For this part (95-6104) and the previous one year (from the notification date) regarding the fracturing of this screw, there is a complaint rate of 0.01% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause is excessive force was applied beyond what the screws are 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.

• Brand Name: 1.5MM SYSTEM HIGH TORGUE (HT), SD, X-DR, SCR, 5/PK
• Common Device Name: ORTHOPEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9813130
• Report Number: 0001032347-2020-00153
• Device Sequence Number: 16894569
• Product Code: GWO
• UDI-Device Identifier: 00841036056650
• UDI-Public: 00841036056650
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121624
• 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): 08/28/2020

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: 95-6104
• Device Lot Number: 390230
• 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: 08/27/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other