MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 912082

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/04/2022

Event Type  Injury  

Event Description

It was reported that during surgery, the tip of the inserter broke and the fractured piece was retained by the patient.No other patient consequences were reported as a result of the event.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Event occurred in (b)(6).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.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the inserter tip is fractured.Not all pieces were returned for evaluation.One prong of the tip is fractured where the tip separates into the two prongs.The plastic sheath is still in place on the end of the inserter.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information 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: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15334329
• MDR Text Key: 299040963
• Report Number: 0001825034-2022-02022
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00880304523418
• UDI-Public: (01)00880304523418(17)261109(10)0002399412
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 912082
• Device Lot Number: 0002399412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose