MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN 8MM DIAMETER INTRAMEDULLARY DRILL WITH STEP; KNEE, PROSTHESIS

Model Number N/A

Device Problem Residue After Decontamination (2325)

Patient Problem No Information (3190)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: quick-connect handle cat#:00590103400 lot#: 63199808, anterior referencing sizer with locking boom cat#:42509908810 lot#:63157869, tibial articular surface provisional left size gh cat#:42517000717 lot#:63222489, tibial sizing plate cemented left cat#:42539908301 lot#:62923736, tibial sizing plate cemented left cat#:42539907901 lot#:62898713, tibial articular surface provisional left size gh cat#:42517000707 lot#:63223617, ps tibial articular surface provisional left size 6-9 gh top cat#:42517400910 lot#:63107270, tibial articular surface provisional left size ef cat#:42517000515 lot#63118802, tibial sizing plate cemented left cat#:42539907501 lot#:63287730, tibial sizing plate cemented left cat#:42539907101 lot#:63287726, tibial articular surface provisional left size ef cat#:42517000505 lot#:63131118, ps tibial articular surface provisional left size 10-11 ef top cat#:42517400810 lot#:63268721, ps tibial articular surface provisional left size 6-9 ef top cat#:42517400710 ot#:63233694, ps tibial articular surface provisional left size 3-5 ef top cat#:42517400610 lot#:63222542, tibial articular surface provisional left size cd, cat#:42517000313 lot#:63039049, tibial sizing plate cemented left cat#:42539906701 lot#:62928197, tibial sizing plate cemented left size c cat#: 42539906401 lot#:62656088, tibial articular surface provisional left size cd cat#:42517000303 lot#:63115046, ps tibial articular surface provisional left size 6-9 cd top cat#:42517400510 lot#:63107264, ps tibial articular surface provisional left size 3-5 cd top cat#:42517400410 lot#:63118803, ps provisional tray left cat#:00590704501 lot#:56610819, modular shell lid gray cat#: 00590707000 lot#:56570792, modular shell lid gray cat#:00590707000 lot#:56610332, modular aluminum single-level shell cat#:00590707100 lot#:56595840.The reported event is confirmed.Visual examination of the returned metal parts determined that they had scratches, water marks, and black staining/residue marks.Visual examination of the returned plastic parts determined that they had scratches and no black residue or visible water marks, which could have been removed during decontamination, were observed.Device history record (dhr) was reviewed and no discrepancies were found.Sem micrographs and eds elemental analysis of the debris on the femoral provisionals, found that there was rust like indication on the laser etched areas of the instruments.The residue showed high concentration of (o, mn and cl) and the debris indication areas were mechanically smeared and were filled with debris which predominantly showed oxides and some areas showed cl, c, si, ca, and al.The root cause for the black residue on the returned instruments is attributed to a maintenance issue due to following reason.All the metallic instruments contained in the trays show water marks.Some of the chemical elements (ca, s, o) do not come from the instruments themselves, but could come from caso4 contained in hard water.The black residue is spread on each and all the metallic instruments, which is only possible through contact with air and water.The recommended cleaning steps were not followed based on the provided information.The hospital reported they had undergone maintenance one week prior to this occurrence.Review of the complaint history determined that no further action is required.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 reports: 0001822565-2018-01611, 0001822565-2018-01612, 0001822565-2018-01613, 0001822565-2018-01614, 0001822565-2018-01615, 0001822565-2018-01616, 0001822565-2018-01617, 0001822565-2018-01618, 0001822565-2018-01619 0001822565-2018-01620, 0001822565-2018-01626, 0001822565-2018-01627, 0001822565-2018-01628 0001822565-2018-01629, 0001822565-2018-01630, 0001822565-2018-01631, 0001822565-2018-01632 0001822565-2018-01633, 0001822565-2018-01634.

Event Description

It was reported during initial operating room setup, the nurse handling the instruments discovered black residue on her gloves.Subsequently, there was noticed to be black debris on some of the instruments.There were five sets examined and all five sets had the same black debris.As a result of the event, the surgery was delayed 35 minutes.Multiple cases and instruments were returned for the reported issue, however it is unclear if these instruments contributed to the reported surgical delay.No additional patient consequences were reported, and the surgery was successfully completed.

• Brand Name: NEXGEN 8MM DIAMETER INTRAMEDULLARY DRILL WITH STEP
• Type of Device: KNEE, PROSTHESIS
• 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: 7381011
• MDR Text Key: 103797549
• Report Number: 0001822565-2018-01609
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/19/2018

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: 00597801400
• Device Lot Number: 63244541
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: Yes
• 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): Hospitalization