MAUDE Adverse Event Report: ZIMMER SPINE REDUCTION MONOAXIAL PEDICLE SCREW DIA.5.5 LG 45; INSTINCT JAVA SYSTEM

Catalog Number 046W0AN65545

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3003853072-2020-00122.

Event Description

It was reported that the threaded shafts of two reduction screws were found bent via x-rays during surgery after being installed.The screws were removed, and are assumed to have been replaced without reported patient impacts.This is report one of two for this event.

Manufacturer Narrative

Summary: the complaint is confirmed for two (2) of two (2) returned 5.5x45mm mono rdctn scr in jva (pn 046w0an65545) for the failure of screws bent during insertion.Visual inspection revealed the screw shanks are bent.Medical records were provided in form of x-ray, the provided x-ray shows that the screws shank are bent.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the screws were being inserted or handled at the time of the damage.Additionally, it is unknown what condition of bone that the patient had as hard bone could also have contributed to this event.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that the threaded shafts of two reduction screws were found bent via x-rays during surgery after being installed.The screws were removed, and are assumed to have been replaced without reported patient impacts.This is report one of two for this event.

• Brand Name: REDUCTION MONOAXIAL PEDICLE SCREW DIA.5.5 LG 45
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 11202540
• MDR Text Key: 228173642
• Report Number: 3003853072-2020-00121
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024341739
• UDI-Public: (01)00889024341739(10)V160028
• Combination Product (y/n): N
• PMA/PMN Number: K111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W0AN65545
• Device Lot Number: V16002876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 78