MAUDE Adverse Event Report: BIOMET MICROFIXATION TEMPOROMANDIBULAR JOINT-PATIENT MATCHED IMPLANT

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history records show the lot released with no recorded anomaly or deviation.The user facility is foreign; therefore a facility medwatch report will not be available.The product was implanted into the patient and therefore will not be returned for an evaluation.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that a template and a fossa implant from a tempormandibular joint (tmj) patient matched implant (pmi) system were missing a hole.It is reported that the surgeon created the missing holes.It was reported that this event presented no delay to the procedure and no injury to the patient.

Manufacturer Narrative

The complaint is the suture hole is missing from the fossa template and implant.The complaint was confirmed through intraoperative pictures.The most likely underlying cause is the design vendor sending the incorrect revision of the cad (computer aided design) file to zimmer biomet for manufacture.

• Brand Name: TEMPOROMANDIBULAR JOINT-PATIENT MATCHED IMPLANT
• Type of Device: PATIENT MATCHED IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6041877
• MDR Text Key: 57931287
• Report Number: 0001032347-2016-00602
• Device Sequence Number: 1
• Product Code: MPI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: N/A
• Device Catalogue Number: TMJPMI-1532
• Device Lot Number: 707830A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 61 YR