MAUDE Adverse Event Report: SYNTHES MEZZOVICO 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.275S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sedation (2368)

Event Date 06/10/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: during a procedure two drill bits broke inside the patient.The first broke while drilling a locking screw in the central hole of the head of the variable angle condylar plate.The second broken drill bit was being used later on during the case to drill at the proximal section of the plate around a hip replacement.It was reported that all broken pieces were retrieved from the patient and there was no harm to patient.The surgery was prolonged by approximately 45 minutes while the drill bits were retrieved.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.Initial reporter: phone/fax: (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No nonconformances were generated during production.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4472059
• MDR Text Key: 5499749
• Report Number: 1000562954-2015-10036
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 02.231.275S
• Device Lot Number: 8678411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR