MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW 10.5X90; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices or x-rays for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(6).

Event Description

It was reported, that the patient was implanted a znn cmn lag screw 10.5x90 on (b)(6) 2014.During the extraction of the lag screw on (b)(6) 2016 the screw has been broken on a par with screw thread.The extraction could not be realized with the screwdriver.It was also reported, that the surgery was extended between 45 min and an hour."following to the breakage, no weight bearing of the leg was allowed for two months, the patient received anticoagulant treatments and underwent regular blood tests.The screw could be removed with a balance weight which was screwed in the inside thread because the unscrewing was not possible anymore.".

Manufacturer Narrative

Dhr review results: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Compatibility of components : the compatibility check could not be performed as only one product was reported to us.The product compatibility check is not relevant for one product only.Trend analysis: no trend identified.Event summary: it was reported that the lag screw tabs were broken during explantation.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents have been received.Devices analysis: visual examination: the broken lag screw was returned for investigation.The visual investigation shows that one lag screw tab sheared off.The broken piece was also returned for evaluation.Root cause analysis: possible root causes, this kind of breakage can occur within the following known situations: within a not fully engaged and securely connected lag screw inserter/ lag screw retaining shaft.If the contact surface of the instrument and implant is too small, too high forces will be transmitted on the cams which leads to a fracture of this section; excessive bone ingrowth onto the lag screw due to long in vivo time of the implant system, which results in high forces being required to remove the screw in a revision case.Some cases are known were a removal was planned 25 month after implantation whereas a fracture should be united within 6-9 month; pathogenic bone diseases (e.G.Bone tumor) which affect mechanical properties of the bone (harder/ denser bone substance).Conclusion summary within a not fully engaged and securely connected lag screw inserter/ lag screw retaining shaft.If the contact surface of the instrument and implant is too small, too high forces will be transmitted on the cams which leads to a fracture of this section: as risk mitigation in the surgical technique it is mentioned that the lag screw inserter and the lag screw must be fully engaged and securely connected.It¿s also mentioned in the clinical evaluation report (cer) as general risk; excessive bone ingrowth onto the lag screw due to long in vivo time of the implant system, which results in high forces being required to remove the screw in a revision case.Some cases are known were a removal was planned 25 month after implantation whereas a fracture should be united within 6-9 month: in the clinical evaluation report it is mentioned that those kind of implants serve as temporary implants and normally are removed after 8-12 month.Any decision to leave the implant in the patient is upon individual decision of the hcp; pathogenic bone diseases (e.G.Bone tumor) which affect mechanical properties of the bone (harder/ denser bone substance): this risk is already addressed in the ifu.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: ZNN CMN LAG SCREW 10.5X90
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer-allee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5510770
• MDR Text Key: 40694934
• Report Number: 9613350-2016-00491
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: 2727491
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 70