MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.3MM DRILL BIT LENGTH 413MM; BIT MILLING STERILE AND NON

Catalog Number 03.168.011

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an open reduction internal fixation (orif) surgery for the femoral neck fracture with femoral neck system (fns).During the procedure, while the surgeon was drilling for the locking screw using the drill bit, it took a longer time than usual.The surgeon heard a friction sound and checked the devices and x-rays, but there were no problems such as loosening of devices.It took more than five (5) minutes to drill until contralateral bone, whereas it takes less than a minute normally.During the drilling, the surgeon pulled out the drill bit two (2) times and removed soft tissues which adhered to the drill bit.The color of the soft tissues had turned black-red.No metal powder was found in the soft tissues.The surgeon mentioned that it didn¿t seem that the drill bit interfered with any metal devices.The surgeon could insert the locking screw and completed the surgery without other problems.There were less than thirty (30) minutes of surgical delay.The patient outcome is unknown.Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 4.3 mm drill bit length 413 mm.This is report 1 of 1 for complaint (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.The drill bit was received with the reported condition of not functioning.Visual inspection confirmed that the drill bit is quite dull, the cutting edges are nicked and rounded.The instrument is in used condition.The complaint condition is confirmed as the drill bit is quite dull.The drill bit was manufactured in june 2017 according to the specifications.After a visual inspection it is determined that the reusable instrument (part# 03.168.011) 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.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Device history lot part: 03.168.011, lot: f-22047, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 09.June 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 MILLING STERILE AND NON
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8813490
• MDR Text Key: 151786293
• Report Number: 8030965-2019-66488
• 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
• Report Date: 06/26/2019

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-22047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING