MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3; BIT,DRILL

Catalog Number 323.062

Device Problem Degraded (1153)

Patient Problem Not Applicable (3189)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.A device history record review was requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the orif (open reduction internal fixation) was applied to distal humeral fractures on (b)(6) 2018.Because drill bits had been degraded, the drill bits could not drill to the bone.The surgery was completed within a 30-minute delay.There was no adverse consequence to the patient.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Date received by manufacturer should have been reported as 6/29/2018 in (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history record (dhr) review: part no.: 323.062; lot no.: l389544; manufacturing location: bettlach; release to warehouse date: 02.May.2017; no nonconformances (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.Investigation summary: investigation selection - investigation site: bettlach; selected flow: device interaction / functional; summary of the manufacturing evaluation - 10 relevant features have been identified.In this line, 5 of these 10 features have been measured and have fulfilled the specifications according to the drawings.On the other hand, 5 features were not measurable: the sharp edges and roughness surface (positions 1 and 2), the primary relief and helix angle (positions 5 and 7) were not measurable due to the heavy prior use of the device, the cutting edges are rounded and partially broken out.The spiral groove is turned open and the chamfer (width of land position 6) is deformed.In addition, during the manufacturing process the lot was inspected 100% according to visual acceptance standard drill-bits bettlach instruction sheet to sharp edges and free of burrs and the whole lot has passed its specifications.The hardness test is not required by the work flow indicated in the investigation procedure, however a hardness test was performed due to is recommended for strong rounded cutting edges.Which it means; when the article has the hardness according to its specification (52 - 55 hrc); this is relevant to drill the bone accurately.The hardness was tested and the result is according to its specifications.Based on the investigation results this complaint is rated as confirmed since the product is rounded and has partially broken out cutting edges in a manner which fits to the described complaint condition.However, from the manufacturing point of view the relevant features measurable have fulfilled the specifications according to the manufacturing process.The rounded and partially broken out cutting edges are the result of heavy prior use and is not indicated due to an error in the production process.No manufacturing issue was identified and/or confirmed during the investigation.No corrective or preventive actions are required.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7440192
• MDR Text Key: 105924041
• Report Number: 8030965-2018-53194
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819166264
• UDI-Public: (01)07611819166264
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 323.062
• Device Lot Number: L389544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1