MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INSERTION JIG 125 DEGREE 1.5M; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Device Damaged Prior to Use (2284); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2015

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint - (b)(4).Complaint sample was evaluated and the reported event was not confirmed.Product left conforming to print as there was no evidence that states otherwise.Per engineer, ¿the only thing that can be said is that they need to put the a/r guide in with the lag screw guide tube as described on page 20 of the attached surgical technique.If they follow this technique then they will see that there is resistance on the a/r guide tube.¿ dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Investigation results concluded that the reported event was related to surgical technique.The condition is addressed in the surgical technique.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

Insertion jig design.

• Brand Name: INSERTION JIG 125 DEGREE 1.5M
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6913564
• MDR Text Key: 88159318
• Report Number: 0001825034-2017-07852
• Device Sequence Number: 1
• Product Code: LHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 211201210
• Device Lot Number: CX2048C02
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1