MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB DRILL BIT WITH QUICK COUPLING 3.3 MM, 195 MM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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 Description

It was reported that during the ncb pp implantation the drill fractured.Tip of the drill remained in patient's bone.

Manufacturer Narrative

Event description: it was reported that on (b)(6) 2019, during the ncb pp implantation the drill fractured.Tip of the drill remained in patient's bone.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the instrument has been returned for investigation.The drill bit was broken in the drilling area.The tip of the device was also returned.There are two fragments available.The event describes that the tip was remained in patient's body.This cannot be confirmed as whole drill bit was returned.No considerable deteriorations, deformations or imperfections can be seen.The part shows some normal signs of usage.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that on (b)(6) 2019, during the ncb pp implantation the drill fractured.Tip of the drill remained in patient's bone.The visual examination showed that the drill bit was brone in the drilling area.All parts were returned for investigation.No pieces were left in patient's body.It can be possible that the drill bit was broken due to overload.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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 Description

No change to previously reported event.

• Brand Name: NCB DRILL BIT WITH QUICK COUPLING 3.3 MM, 195 MM
• Type of Device: NCB 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: 9529049
• MDR Text Key: 174212589
• Report Number: 0009613350-2019-00819
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00889024505421
• UDI-Public: 00889024505421
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.00024.118
• Device Lot Number: 4501399974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other