MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, DF TARGETING INSTRUMENT FOR LEFT PLATES; NCB PLATING SYSTEM DISTAL FEMUR AND PROXIMAL TIBIA

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the carbon holding device burst.
Additional Manufacturer Narrative
The manufacturer did not receive any source of documents for review.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.As no lot number was provided, 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.(b)(4).
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Review of event description: the carbon holding device burst.The damage was probably already present before the operation, but was noticed during the operation.Patient involvement-prolonged surgery (90 min).Review of received data: no medical data relevant to the case has been received.Product evaluation: visual examination: the targeting device was returned for an investigation.One of the retainer jaws shows a crack.It is unknown when exactly and how this crack was occurred.No other conspicuousness found.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of surgical technique: in the surgical technique it is described that the plate should be attached with both connection bolts on the targeting device, to ensure a secure connection and to avoid an overstrain of the retainer jaws.Like this the applied force is transferred only via the connection bolts, but not via the connection to the plate.Conclusion: the targeting device was damaged.The damage was probably already present before the operation, but was noticed during the operation.The instrument has been returned for an investigation.There has been a crack in one of the retainer jaw.It is important to attach the plate with both connection bolts on the targeting device, to ensure a secure connection and to avoid an overstrain of the retainer jaws.If these instructions as in the surgical technique mentioned are followed, the applied force will be transferred only via the connection bolts, but not via the connection to the plate.It remains unknown if the handling of the device was not clear and if the surgical technique was followed.Additionally, as the instrument has been manufactured in 2008 it might have been on the market for more than 11 years and used excessively.However, an exact root cause for the crack on the instrument could not be determined the investigation did not identify a nonconformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
This followup is being submitted due to additional information received after the investigation.The event description in section h10 has been updated.The conclusion of the investigation however did not change.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Investigation and conclusion 1.Event description: the targeting device was damaged.The operation was prolonged because the insertion handle broke intra-operatively.There has been a crack in one of the retainer jaw.Patient involvement-prolonged surgery.(90 min).Harm: s2 - exposure to anesthesia, minor (as no serious injury occurred due to anesthesia extension) hazardous situation: instrument breaks, diverges or becomes damaged and non-functional during surgical procedure.2.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Product evaluation: visual examination: the targeting device was returned for an investigation.One of the retainer jaws shows a crack.Based on the information provided, the instrument broke intra-operatively.No other conspicuousness found.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: reported event is not related to a combination of products; therefore a compatibility review is not applicable.Surgical technique sap: in the surgical technique it is described that the plate should be attached with both connection bolts on the targeting device, to ensure a secure connection and to avoid an overstrain of the retainer jaws.Like this the applied force is transferred only via the connection bolts, but not via the connection to the plate.5.Conclusion: the targeting device was damaged.The operation was prolonged because the insertion handle broke intra-operatively.The instrument has been returned for an investigation.There has been a crack in one of the retainer jaw.It is important to attach the plate with both connection bolts on the targeting device, to ensure a secure connection and to avoid an overstrain of the retainer jaws.If these instructions as in the surgical technique mentioned are followed, the applied force will be transferred only via the connection bolts, but not via the connection to the plate.It remains unknown if the handling of the device was not clear and if the surgical technique was followed.Additionally, as the instrument has been manufactured in 2008 it might have been on the market for more than 11 years and used excessively.However, an exact root cause for the crack on the instrument could not be determined the investigation did not identify a nonconformance or a complaint out of box (coob).If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: NCB, DF TARGETING INSTRUMENT FOR LEFT PLATES
• Common Device Name: NCB PLATING SYSTEM DISTAL FEMUR AND PROXIMAL TIBIA
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 12860804
• Report Number: 0009613350-2021-00601
• Device Sequence Number: 4205118
• Product Code: HRS
• UDI-Device Identifier: 00889024289451
• UDI-Public: 00889024289451
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.00024.071
• Device Lot Number: 08.360965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 01/10/2022; 02/10/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/13/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Patient Sex: Unknown