MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEINMANN PINS 2.8 MM (7/64 IN) DIAMETER 22.9 CM (9 IN) LENGTH STYLE 5; ORTHOPAEDIC BONE PIN

Catalog Number 47018700359

Device Problem Fracture (1260)

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

Event Date 08/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during an unknown procedure on an unknown date, while the pin was being placed into the patient's leg, the tip of the pin fractured in the patient's leg.All pieces were received with no harm to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that during a left lower extremity wound debridement, fracture debridement, spanning external fixation, and fasciotomy, while the pin was being placed into the patient's leg, the tip of the pin broke in the patient's leg.All pieces were received with no harm to the patient.

Manufacturer Narrative

Review of the device history records identified no deviations or anomalies during manufacturing no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A definitive root cause could not 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.

• Brand Name: STEINMANN PINS 2.8 MM (7/64 IN) DIAMETER 22.9 CM (9 IN) LENGTH STYLE 5
• Type of Device: ORTHOPAEDIC BONE PIN
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10752161
• MDR Text Key: 213699332
• Report Number: 0001822565-2020-03581
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K143618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

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 Catalogue Number: 47018700359
• Device Lot Number: 64713946
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR