MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 100 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is 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.(b)(4).
Event or Problem Description
It was reported that during the removal process, the fins of the lag screw broke off and it could not be removed.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.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 or Problem Description
In addition to report 0009613350-2019-00381, 1 screw (locking screw) could be removed.Two fins of the second (cervical) screw broke.The screw could be screwed out 1cm and then the screw was attempted to be removed with pliers, however without any success.Total delay report, 1 hour.
Additional Manufacturer Narrative
Investigation results were made available.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: part specific investigation: no trigger considering the following event is identified: device fracture.Lot specific investigation: no lot trigger: no similar investigated events for the same lot numbers: 2869574 have been found.Review of event description: it was reported that the patient had a revision surgery approximately two years post implantation for removal of the implants.During the removal process, the fins of the lag screw broke off and it couldn't be removed.The surgery was delayed for 1 hour.Review of received data: implantation report, on (b)(6) 2017: indication: fracture trochanter right side.Procedure: the screws were placed without any problems.After the anti-rotation screw the distal locking screw was placed.The implant was verified with x-rays.Explantation report, on (b)(6) 2019: one screw (distal locking screw) could be removed.Then the distal cervical screw was removed.Two fins of the third (cervical) screw broke.The screw could be screwed out 1cm and then the screw was attempted to be removed with pliers, however without any success.The nail and the cervical screw remained implanted.The procedure was delayed for 1 hour.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.The nail and the cervical screw remained implanted.Review of product documentation: this device is intended for treatment.Compatibility: compatibility check could not be performed as only one product has been reported.Surgical technique: the removal of the lag screw is described in the zimmer natural nail system cephalomedullary standard surgical technique.Conclusion summary: it was reported that the patient had a revision surgery approximately two years post implantation to remove the implants.Two screws could be removed.During the removal process, the fins of the cervical screw broke off and it couldn't be removed.The surgery was delayed for 1 hour.The correct removal of the lag screw is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.It was reported that the devices remains in the patient.There are possible causes for the breakage of the screw during the removal of the znn nailing system: if the contact surface of the instrument and implant is too small, too high forces will be transmitted on the cams which lead to a fracture of this section.Excessive bone ingrowth onto the lag screw due to long in vivo time of the implant system, which makes high forces needed to remove the screw in a removal case.The in vivo time was approx.2 years.Pathogenic bone diseases (e.G.Bone tumor) which affect mechanical properties of the bone (harder/ denser bone substance).The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 100 MM, INCLUDING SET SCREW
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8690333
• Report Number: 0009613350-2019-00381
• Device Sequence Number: 19246162
• Product Code: HSB
• UDI-Device Identifier: 00889024298453
• UDI-Public: 00889024298453
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-100-10
• Device Lot Number: 2869574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/17/2019; 12/13/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 08/06/2019; 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Weight: 82