MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 00223200418

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: cable cerclage cable, cat#: 00223200418, lot#: ni.Cable cerclage cable, cat#: 00223200418, lot#: ni.Cable cerclage cable, cat#: 00223200418, lot#: ni.Cable cerclage cable, cat#: 00223200418, lot#: ni.Cable cerclage cable, cat#: 00223200418, lot#: ni.Cable cerclage cable, cat#: 00223200418, lot#: ni.Report source: foreign country: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05488, 0001822565 - 2019 - 05489, 0001822565 - 2019 - 05490, 0001822565 - 2019 - 05491, 0001822565 - 2019 - 05493, 0001822565 - 2019 - 05494.

Event Description

It was reported that when cables were tensioned some strands broke and the cables needed to be cut to get the tensioning clamp off.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

13 lot numbers were received for this complaint.It is unknown which 7 of the 13 lot numbers malfunctioned.Please see the below product information: cat: 22320418 lot: 64297449 qty 1 exp date: 31 jan 2029 udi: (b)(4) cat: 22320418 lot: 64245448 qty 1 exp date: 30 nov 2028 udi: (b)(4) cat: 22320418 lot: 64297408 qty 1 exp date: 31 jan 2029 udi: (b)(4) cat: 22320418 lot: 64230631 qty 1 exp date: 30 nov 2028 udi: (b)(4) cat: 22320418 lot: 63759966 qty 1 exp date: 31 aug 2027 udi: (b)(4) cat: 22320418 lot: 64479177 qty 1 exp date: 31 jul 2029 udi: (b)(4) cat: 22320418 lot: 64123313 qty 1 exp date: 31 jul 2028 udi: (b)(4) cat: 22320418 lot: 64536598 qty 1 exp date: 30 sep 2029 udi: (b)(4) cat: 22320418 lot: 64500356 qty 2 exp date: 31 aug 2029 udi: (b)(4) cat: 22320418 lot: 64523103 qty 3 exp date: 30 sep 2029 udi: (b)(4).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were : updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Visual examination of the provided pictures identified the cables are frayed and fractured.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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

No further event information available at the time of this report.

• Brand Name: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9534984
• MDR Text Key: 199668795
• Report Number: 0001822565-2019-05492
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K151907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00223200418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Weight: 120