MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY CONNECTING BOLT INSERTER ROD, FIXATION

Model Number N/A

Device Problems Crack (1135); Fracture (1260); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Medical devices: (b)(4), cephalomedullary connecting bolt inserter, (b)(4), (b)(4), cephalomedullary connecting bolt inserter, (b)(4), (b)(4), captured screwdriver freehand, (b)(4). Report source, foreign - the 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01128, 0001822565 - 2018 - 01129, 0001822565 - 2018 - 01127.

Event Description

It was reported that the handle of the inserter was cracked. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4). Complaint sample was evaluated and the reported event was confirmed. Visual inspection of the returned screwdriver confirmed that the blue handle cracked. Also noted multiple scratches on the handle indicative of use. The device history records were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified. Root cause was unable to 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: CEPHALOMEDULLARY CONNECTING BOLT INSERTER
• Type of Device: ROD, FIXATION
• 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: 7298710
• MDR Text Key: 101163319
• Report Number: 0001822565-2018-01130
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 00249003280
• Device Lot Number: 63647091
• Other Device ID Number: (01) 00889024063556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: N/A