MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.5MM #2 MB SNGL; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number 912031

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdrs were filed in association with this event.Please see: 0001825034-2019-02792, 0001825034-2019-02793, 0001825034-2019-02794, 0001825034-2019-02799, 0001825034-2019-02800, 0001825034-2019-02801, 0001825034-2019-02802, 0001825034-2019-02803, 0001825034-2019-02804, 0001825034-2019-02805, 0001825034-2019-02807.Concomitant medical products: 908646 washerloc cortical screw 46mm, lot 305460.906513 tunneloc fixation lot 465065.904781 standard ezloc lot 576530.904755 ziploop lot p08647.904056 ez pass lot 545450.904055 ez pass lot 359600.904053 ez pass lot 048410.900321 maxfire lot 909090.904760 toggle drill lot 699980.912031 juggerknot lot p09905.912029 juggerknot lot p08797.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported packaging damage event was confirmed via visual examination.It was identified the packaging was damaged at an unknown time.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.The likely condition of the product when leaving zimmer biomet was conforming to specifications.A definite root cause of the reported issue cannot 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.

Event Description

No further information available at the time of this reporting.

• Brand Name: JGRKNT 1.5MM #2 MB SNGL
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8743557
• MDR Text Key: 198782505
• Report Number: 0001825034-2019-02806
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K150768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Catalogue Number: 912031
• Device Lot Number: P09905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1