MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DRILL BIT WITH QUICK COUPLING, 2-FLUTED, 2.5 MM, 154/180 MM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received 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.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
During surgery, the surgeon noticed that the drill bit was fractured.The fractured pieces were not removed from the patient.
Additional Manufacturer Narrative
Investigation results were made available.Event description: event happened during the surgery when the surgeon noticed that the drill bit fractured.The fractured pieces were not removed from the patient.Review of received data: images: the received image was reviewed.It can be confirmed that the tip of the drill is broken off.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification (lot number unknown).Device purpose: this device is intended for treatment.Surgical technique: the surgical technique for the ncb distal femur was reviewed.It is mentioned that in case of good bone quality it is recommended to drill the cortex with a 4.3mm drill bit.Moreover in all figures of the drilling process, a drilling perpendicular to the bone surface is illustrated.Conclusion: event happened during the surgery when the surgeon noticed that the drill bit fractured.The fractured pieces were not removed from the patient.Based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).It is advised to monitor the patient, as the broken off tip remained inside the patient's body.In accordance with iso 10993-1 the trauma instruments group 1: cutting and drilling instruments are categorized as external communicating devices with tissue/bone contact for less than 24 hours.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
Investigation results are available now.

• Brand Name: DRILL BIT WITH QUICK COUPLING, 2-FLUTED, 2.5 MM, 154/180 MM
• Common Device Name: DRILL BIT WITH QUICK COUPLING
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10419147
• Report Number: 0009613350-2020-00383
• Device Sequence Number: 3395114
• Product Code: HTW
• UDI-Device Identifier: 00889024298064
• UDI-Public: 00889024298064
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 103.25.180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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: Hospitalization