MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.2MM X 560MM COCR THD TIP; PIN, FIXATION

Model Number N/A

Device Problems Fracture (1260); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Medical product - fem nail troch lt 12mmx400mm, cat#: 14-443540 lot#: 579730; antegrade femoral nail driver, cat#: 14-442017 lot#: ni; recon targeting arm, cat#: 14-442018 lot#: ni.Customer has indicated that the product will not be returned [surgeon did not approve for return] to zimmer biomet for investigation.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 a trauma procedure the guide wire tip fractured inside the patient's wound after hitting the nail.The nail was extracted and was reinserted however the drill bit struck the nail again.The nail was extracted a second time and a different system was used to complete the procedure.The guide wire tip was unable to be removed from the patient's wound.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

It was identified that the initial report was submitted on (b)(6) 2017 according to the initial aware date.However, the initial report should have been submitted prior to(b)(6) 2017, as the correct aware date was discovered to be (b)(6) 2017.

Manufacturer Narrative

(b)(4).Concomitant medical products: fem nail troch lt 12mmx400mm, cat#: 14-443540 lot#: 579730 antegrade femoral nail driver, cat#: 14-442017 lot#: unk recon targeting arm, cat#: 14-442018 lot#: unk recon drill 6mm x 489mm cat#: 14-442023 lot#: unk.The reported event could not be confirmed.Guide wire was discarded and thus not returned.Nail was returned, and the visual inspection of the returned product identified extensive damage to the holes of the nail.Due to the scratches and deformation to the proximal holes, no accurate dimensional analysis or functional testing can be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2018-02220.

Event Description

It was reported that during a femoral nail procedure, the guide wire tip fractured off inside the patient's wound after hitting the nail, despite proper targeting and alignment during testing prior to device insertion into the patient.The nail was extracted and was reinserted, however the drill bit struck the nail again.The nail was extracted a second time and a different system was used to complete the procedure.The guide wire tip was unable to be removed from the patient's wound.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: 3.2MM X 560MM COCR THD TIP
• Type of Device: PIN, 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: 6945415
• MDR Text Key: 89347354
• Report Number: 0001825034-2017-08539
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK831005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 14-441053
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 03/08/2018; 09/02/2017
• Supplement Dates FDA Received: 03/26/2018; 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention