MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, DF DRILL BIT, 4.3, LENGTH 300 MM; N/A

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical products: drill bit with quick-coupling 4.3 mm diameter long; catalog#: 02.02024.346; lot#: unknown.Therapy date: unknown.The manufacturer received other source of 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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
During an initial surgery the 4.3mm instruments drill bit did not cut well due to instrument wear.There was a surgical delay of about 30 minutes due to instrument wear.The patient was anesthetized but finally the surgery was performed according to the procedure.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
Additional Manufacturer Narrative
The reported event has been corrected.The surgical delay is only around 15 minutes.This incident is therefore not considered as reportable anymore, as no harm or injury occurred according to the available information.Furthermore, the quality records show that all specified characteristics have met the specifications valid at the time of production.The visual examination of the returned device showed that the drill bit has worn cutting edges due to repeated use.Please delete this case from your records.Zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Update: it was additionally reported that the surgical delay was around 15 minutes, not greater than 30 minutes as previously communicated.

• Brand Name: NCB, DF DRILL BIT, 4.3, LENGTH 300 MM
• Common Device Name: N/A
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11292548
• Report Number: 0009613350-2021-00068
• Device Sequence Number: 4279950
• Product Code: HRS
• UDI-Device Identifier: 00889024289277
• UDI-Public: 00889024289277
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N/A
• 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
• Report Date (Section B): 03/11/2021

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: 0200024002
• Device Lot Number: 4501452115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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