MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL FLEXIBLE CANNULATED REAMER 5.5 MM DIAMETER; PROTHESIS, ELBOW

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The complaint was confirmed as product was returned.Two flexible reamers are returned for evaluation.Lot 63134901 reamer was fractured and an unknown pin remains inside the cannulation.Material composition confirmed devices were conforming to specifications.Sem analysis concluded "based upon visual examination of fracture artifacts, both reamer shafts likely fractured as a result of torsional overloads." dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.A definite root cause cannot be determined with the information provided.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

It was reported that during ulnar preparation for an elbow arthroplasty procedure, the reamer fractured inside patient's bone.No fractured pieces fell into the patient, and the patient did not retain any foreign bodies.A new 7mm reamer was used to complete the procedure with minimal delay to procedure.No further patient consequences reported.No additional information is available.

• Brand Name: NEXEL FLEXIBLE CANNULATED REAMER 5.5 MM DIAMETER
• Type of Device: PROTHESIS, ELBOW
• 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: 7426260
• MDR Text Key: 105315907
• Report Number: 0001822565-2018-02106
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00840107201
• Device Lot Number: 63134901
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention