MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW TRAUMA

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Additional information has been requested on april 13, 2017.(b)(4).

Event Description

It was reported that the patient was implanted a znn cmn lag screw trauma on unknown date.The following statement was reported "an x-ray showed that the lag screw is potentially long and perforated into the acetabular space.On further examination, it also appears that there is an end cap that has been inserted into the lag screw which will increase the difficulty of the procedure to remove the nail lag screw.".

Manufacturer Narrative

A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer¿s reference number of this file is cmp-(b)(4).

Event Description

It was now reported, that the nail was explanted (exact date unknown).

Manufacturer Narrative

Investigation results were made available: as for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive more information for this case.Additional information was requested at complainant the latest one on (b)(4) 2017.It was explained that the nail has been implanted in ibiza and that the devices data are therefore not available at the healthcare facility were the revision surgery occurred.It was further reported that the device has been destroyed after the revision surgery as there was no fault with the product itself causing the issue.Trend analysis: no trend analysis could be performed as no item number was available.Device history records (dhr): as no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device data information was requested, but was not available.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Review of event description: a revision of a znn cmn nail and znn cmn lag screw has been performed due to hip pain.It was reported that xray show that the lag screw is potentially long and perforated into the acetabular space.There was no end cap in the nail but it had perforated the femoral head.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.The product has been discarded by the hospital.Root cause analysis: root cause determination using rmw: implant migration due to mri interacts with titan implant components => possible, no information received about surgical procedure or x-ray control.Lag screw migration due to incorrect lag screw design results into cut out => not possible -> a systematic issue with design and/or material properties would have been detected as part of a trend review.Failure of surgery due to use of the device not compliant with defined indications => possible, no information received about surgical procedure.Indications are not known.Failure of surgery due to wrong selection of components or use in combination with device outside the znn cmn system => possible, it is not known how the devices were used.No detailed information was received.Lag screw migration due to users determine wrong lag screw length => possible, it is possible that the cut out occurred due to wrong lag screw length.No x-rays have been received.It cannot be confirmed.Lag screw migration due to users apply set screw not correctly (lag screw groove not engaged) => possible, it is not known if a set screw was used.If yes, it is also unknown if the set screw was used correctly.Failure of surgery due to missing/incomplete information available, misleading information of surgical technique and/or instructions for use => not possible -> no issue in surgical technique.Failure of surgery due to wrong/misleading information of labels => not possible -> no wrong information of labels.Failure of surgery due to insufficient warning of side effects => not possible -> no issue with of side effects.Conclusion summary: it was reported that the lag screw is potentially long and perforated into the acetabular space.No surgical reports and x-rays were received.The affected devices have also not been returned for investigation.The surgical technique describes the following: a set screw (included in the lag screw package or packaged separately) must be used to prevent the lag screw from rotating post-operatively.The set screw should be tightened down into the groove in the lag screw.The lag screw inserter must be positioned so that the handle on the inserter is parallel or perpendicular to the colored dots on the targeting guide in order for the set screw and lag screw grooves to engage properly.To verify engagement, attempt to twist the lag screw inserter.If it cannot be rotated using a reasonable amount of force, the construct is in the correct position.If rotation is possible, adjust the position of the lag screw (rotate slightly) so that the set screw can enter the groove in the lag screw.To achieve sliding, tighten the set screw and then rotate the set screw inserter counter clockwise one quarter turn.Do not unscrew the set screw more than one quarter turn.Do not over tighten the lag screw.The distal edge must protrude laterally through the femur to ensure that sliding can occur.The reported event describes that the lag screw was chosen potentially long.This can be a cause for the migration.It is also not known if a set screw was used in the surgery to prevent the lag screw from rotating post-operatively.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: ZNN CMN LAG SCREW TRAUMA
• Type of Device: ZNN CMN LAG SCREW TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6499590
• MDR Text Key: 73021157
• Report Number: 0009613350-2017-00505
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• 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,Followup
• Report Date: 04/18/2017

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided; 07/04/2017
• Supplement Dates FDA Received: 06/06/2017; 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention