MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.3MM DRILL BIT LENGTH 413MM; BIT, SURGICAL

Catalog Number 03.168.011

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent an open reduction internal fixation surgery for femoral neck fracture with the drill bit in question.During the surgery, the drill bit was dull.The surgery was delayed by less than 30 minutes.It was not reported how the surgery was finished.No further information is available.This report is for one (1) 4.3mm drill bit length 413mm this is report 1 of 1 for (b)(4).

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.H11: corrected data: g4: awareness date reported on follow up 1 report as january 06, 2020 but should have been february 2, 2020.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 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.H3, h6; part: 03.168.011, lot: f-20966, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 12.October 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation site: cq zuchwil, selected flow: damage.Visual inspection: the received drill bit is worn form regular use and therefore dull as complained.No other damages are visible.Summary the complaint condition is confirmed as the drill bit is worn.After a visual inspection per guidance, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 4.3MM DRILL BIT LENGTH 413MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9637560
• MDR Text Key: 194552028
• Report Number: 8030965-2020-00685
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 07611819657373
• UDI-Public: (01)07611819657373
• 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,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.168.011
• Device Lot Number: F-20966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 01/06/2020; 02/27/2020; 03/02/2020
• Supplement Dates FDA Received: 02/26/2020; 02/27/2020; 03/25/2020
• Patient Sequence Number: 1