MAUDE Adverse Event Report: ZIMMER GMBH SET SCREW, 8 MM, 21 MM, HEX 3.5 MM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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 biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a unknown znn cmn trauma screw on an unknown date and the patient underwent revision surgery on (b)(6) 2017 due to unknown reason.It was also reported that it was impossible to remove the locking screw, therefore it was also not possible to remove the implant.Due to this, an involuntary retain of the device in the patient was "forced".

Manufacturer Narrative

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.The missing information was requested at complainant the latest one on (b)(6) 2017 but was not available.A technical investigation was not possible to perform, as the device(s) were not at hand for investigation.Device history records (dhr) as no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer (b)(4) 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 (b)(4) 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.Trend analysis: no trend considering the following event is identified: difficulties to remove the set screw.Review of event description: it was reported that it was impossible to remove the set screw, therefore it was also not possible to remove all the implants.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the removal of the znn nailing system is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique 97-2493-002-00.This surgical technique describes that the use of a nail cap to close the proximal part of the nail to prevent bone ingrowth is recommended.The set screw extraction is described on page 26: "remove the screws using a 3.5 mm hex screw driver.Remove the nail cap (if one was inserted) with a 5.0 mm hex screw driver.Use a 3.5 mm hex screw driver to remove the set screw." root cause determination using rmw: damage of the implant (set screw) due to lack of adequate set screws design for insertion and extraction.=> not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Damage of the implant (hex-stripping) due to lack of adequate nail cap and set screws design for extraction.=> not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Failure of surgery due to wrong selection of components or use in combination with device outside the znn cmn system.=> possible, it is possible that the user did not use the appropriate screwdriver to remove the set screw and was therefore not able to remove the set screw.Failure of surgery due to missing/incomplete information available, misleading information of surgical technique and/or instructions for use.=> not possible -> no issue identified with the surgical technique and/or instructions for use.Conclusion summary: it was reported that it was impossible to remove the set screw, therefore it was also not possible to remove all the implants.No devices have been returned to zimmer biomet for in-depth analysis.However, it is unknown when the znn nailing system was implanted.Therefore, the in vivo time until this event occurred is unknown.There are two most possible factors which may have contributed to the reported event.If no nail cap was implanted, it can be assumed that there was bone ingrowth in the proximal part of the nail where the set screw was inserted.It is possible that the bone ingrowth did not allow to remove the set screw.No information was provided if a nail cap was used to prevent bone ingrowth as described in the surgical technique.Another possibility is that the user did not use the appropriate screwdriver to remove the set screw and was therefore not able to remove the set screw.However, an exact root cause for the reported event could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

It was reported that it was impossible to remove the znn cmn set screw during surgery, therefore it was also not possible to remove the implant.Due to this, an involuntary retain of the device in the patient was "forced".

• Brand Name: SET SCREW, 8 MM, 21 MM, HEX 3.5 MM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6950767
• MDR Text Key: 89352776
• Report Number: 0009613350-2017-01443
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• 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: 47-2493-000-00
• Device Lot Number: UNKOWN
• Other Device ID Number: 00889024298620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• 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): Other