MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM; BIT,DRILL

Catalog Number 323.062

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight not available for reporting.Patient date of birth not available for reporting, age reported as (b)(6).Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.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 patient underwent an open reduction internal fixation (orif) for distal humeral fractures on (b)(6) 2018.The drill bit was used in previous surgical procedures without issue, but was not able to drill through the bone in this procedure.Surgery was completed with a delay of approximately 30 minutes utilizing kirshner wires (k-wires).No adverse consequence to the patient was reported.Surgeon commented that patient¿s bone quality did not seem hard.This report is for one 2.0mm drill bit.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.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.H10 additional narrative: h3, h4, h6: dhr review was completed.Part no.: 323.062.Lot no.: l533514.Manufacturing location: bettlach.Release to warehouse date: 29.Aug.2017.No 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.H3, h6: customer quality conducted an investigation of the returned device investigation selection.Investigation site: bettlach.Selected flow(s): 2.Device interaction/functional.Visual inspection: the product was returned in a packaging different to the original synthes bag.The article no.323.062 and lot number l533514 correspond to the information in the complaint details.The laser marking is readable.Traces of use are visible at the tip and shaft (see pictures below).No further damages which could lead to the complaint condition were found.Functional test: during the manufacturing process there is no functional test defined for this product.Therefore, this section is covered through the dimensional inspection.Drawing/specification review: the review of the dhr of article 323.062 lot: l533514 showed that there were no issues during the manufacture of the product.No ncs were generated during the production of the lot in question.Dimensional inspection: all relevant features have been measured and have fulfilled the specifications -except for the sharp edges according to the drawings.The sharp edges and free of burrs feature was not measurable due to the heavy prior use of the device, the cutting edges are rounded.Material or hardness review: the hardness test is not required by the work flow indicated in the procedure w-m-s080 rev.8, 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 the drawing.Summary: based on the investigation results this complaint is rated as confirmed since the product is rounded in a manner which fits to the described complaint condition.However, from the manufacturing point of view the relevant features were measured and have fulfilled the specifications according to the manufacturing process (see section dimensional inspection).The rounded cutting edges are the result of heavy prior use and is not indicated due to an error in the production process.Therefore, no manufacturing issue was identified and/or confirmed during the investigation.No corrective or preventive actions are required.To prevent such problems, it is necessary worn or damaged instruments to replace.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7441210
• MDR Text Key: 105921914
• Report Number: 8030965-2018-53208
• 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: 03/30/2018

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 Catalogue Number: 323.062
• Device Lot Number: L533514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 06/28/2018
• Supplement Dates FDA Received: 04/19/2018; 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention