MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW 10.5 MM, 90 MM, INCLUDING SET SCREW

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/28/2019
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.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 or Problem Description
Patient was implanted with a znn cpm lag screw.When the nail was tried to be removed, the fins of the screw broke making it impossible for the nail to be removed.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device history record (dhr) was reviewed and no discrepancies were found.Surgical report was received and will be reviewed as part of ongoing investigation.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
No change to previously reported event.
Event or Problem Description
Please refer to report 0009613350-2019-00372.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: device fracture resp.Medical other.Event description: it was reported that a patient received an implant on (b)(6) 2017 and underwent revision surgery on (b)(6) 2019 due to infection which failed due to material fracture.Review of received data: bone fracture caused by metastasis from breast cancer.Surgical notes from initial surgery dated (b)(6) 2017: implantation of a nail 10mmx21,5cm znn without difficulties.Placement of a neck-screw.Placement of two screws for distal locking.Surgical notes from revision surgery dated (b)(6) 2019: revision surgery due to infection (osteosynthesis at level of left femur).During removal of screw material fractured.It was impossible to remove the nail and the screw.Device analysis: no product was returned to zimmer biomet for in-depth analysis as it remains implanted.Review of product documentation: all involved devices are 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: it was reported that during surgery to remove the znn system the notches of a screw broke off on (b)(6) 2019.The broken pieces were not returned.The correct removal of the lag screw is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique 97-2493-002-00.It was reported that the devices remain 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).

• Brand Name: ZNN CMN LAG SCREW 10.5 MM, 90 MM, INCLUDING SET SCREW
• Common Device Name: ZNN CMN LAG SCREW
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8685947
• Report Number: 0009613350-2019-00372
• Device Sequence Number: 2935081
• Product Code: HSB
• UDI-Device Identifier: 00889024298439
• UDI-Public: 00889024298439
• 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): 11/26/2019

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: 2858447
• 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: 08/14/2019; 11/18/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 09/10/2019; 11/26/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 51