MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STN PN THD TIP .125X2.5IN 2PK; INSTRUMENTS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 32-486259, vngd shortquick-release drill huck, zb151001; 407396, comp primary i/m guide block, 045420.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02975.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during procedure, the release drill huck did not hook the pins.The pin was fractured and stuck inside the guide block component.It was not possible to take it out.It is not sure if any piece remains in the patient.The pin was fractured because the surgeon did not take out the yellow drill and the drill hit the pin.The guide block component did not close properly and they had to tight with another piece.The result of surgery was satisfactory, the surgical steps were followed and the event with the pin was due to the hit of the drill and the problem was solved when the drill was taken out.No more information available.

Event Description

No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was confirmed; the fractured tip of the pin was returned stuck in the cut guide.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed.

• Brand Name: STN PN THD TIP .125X2.5IN 2PK
• Type of Device: INSTRUMENTS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8784539
• MDR Text Key: 150827277
• Report Number: 0001825034-2019-02974
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 406669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization