MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 130 DEG 9MM X 180MM; ROD, FIXATION

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see report(s): 0001825034 - 2018 - 00494.Concomitant medical products: unknown part/lot; jig bolt, 281001004 t-handle hudson, lot fa7n74, 281013037 flexible jig bolt driver 8mm, lot nm1210, 211201201 insertion jig 130 degree, lot e73dg4.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the bolt would not release during removal of the jig.The nail was removed after a 15 minute delay to surgery and the bolt was able to release.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.It is unknown with which lot number pn: 814509180 was released to.It is one of the following possible lot combinations: lot# 118760, sterile expiration date: may 1, 2027.Lot# 099480, sterile expiration date: apr 23, 2027.Lot# 099470, sterile expiration date: apr 22, 2027.Medical product: insertion jig bolt, cat#: 211201202 lot#: e28dv4.Hfn 130 deg 9mm x 180mm, cat#: 814509180 lot#: 118760, 099480, or 099470.T-handle hudson, cat#: 281001004 lot#: fa7n74.Insertion jig 130 degree, cat#: 211201201 lot#: e73dg4.Flexible jig bolt driver 8mm, cat#: 281013037 lot#: nm1210.Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi # (b)(4).Complaint sample was evaluated and the reported event was not confirmed.The visual evaluation revealed that the jig bolt driver was noted to be fractured.The jig was removed from the nail with an allen wrench with minimal effort.Once removed, it was noted that the threads of both the jig bolt and the nail are undamaged, and the bolt and nail are able to assemble and disassemble as expected.Device history record was reviewed and no discrepancies were found.The root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: HFN 130 DEG 9MM X 180MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7238650
• MDR Text Key: 99190648
• Report Number: 0001825034-2018-00495
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2019

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
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 814509180
• Device Lot Number: SEE H10
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 05/10/2018; 01/08/2019
• Supplement Dates FDA Received: 06/06/2018; 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 61