MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REAMER Ø11 F/PFNA BLADE

Catalog Number 356.821

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 10/21/2018

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).A review of the device history records has been requested.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a proximal femoral nail antirotaion (pfna) was used on an orthopedic procedure on (b)(6) 2018.During insertion of the right nail and guide wire, the lateral cortex was drilled and tried to ream the femur head but the reamer broke.The implant was changed into a2fn recon and tried to find the optimum position for recon hip screw, while drilling for recon hip screw, the drill bit was broken.The implant was changed again to a standard locking a2fn.It is unknown how the surgery was completed.The procedure was delayed four hours and required prolonged anesthesia on the patient.This complaint is for one (1) reamer concomitant device reported: unknown drill guide: (part# unknown, lot# unknown, quantity# 1), unknown nail (part# unknown, lot# unknown, quantity# 1), unknown guide wire (part# unknown, lot# unknown, quantity# 1).This complaint involves three (3) devices this report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part: 356.821, lot: u200200.Manufacturing location: (b)(4), release to warehouse date: apr 24, 2014.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The material was reviewed, and the hardness value was confirmed to meet the specification with no non-conformance noted.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.The complete 6mm diameter part of the reamer is broken off, the fragment is not available for investigation.At the remaining working end, the reamer ø11 f/pfna blade shows damage and wear on all cutting edges.The material was reviewed and the hardness value was confirmed to meet the specification with no non-conformance noted.The used material was stainless steel as required.The hardness was with 54.04 hrc within the specification of 52 hrc +3/0.The received condition agree with the complaint description and the complaint therefore is confirmed.The visual defects on the remaining drill flanks of the four years old reamer coincide and provide evidence that at the time of surgery the device was subjected to mechanical overloading.Based on our investigations a product related fault can be excluded.The reamers 356.821 are multi use instruments, therefore, the condition of the cutting blades prior to the operation in question is unknown.The important information leaflet describes the recommended instrument inspections for reprocessing operations before reusable device operations.No manufacturing related issue was identified and/or confirmed.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Facility telephone: (b)(6).A review of the device history records has been requested.The device was received, the investigation is in progess, no conclusion could be drawn at the time of filing this report.Corrected data: catalog, udi physical manufacture site 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

It was reported that patient underwent a procedure to implant the proximal femoral nail antirotation (pfna) nail on october 21, 2018.During the procedure, the guide wire was inserted, the lateral cortex was drilled, and surgeon attempted to ream the femur head when the reamer broke.Surgical plan was changed to implant the a2fn reconstruction nail.Surgeon attempted to find the optimum position for the reconstruction hip screw but the drill bit broke while drilling for the hip screw.Surgeon then changed to a standard locking a2fn nail.Surgery was delayed approximately four (4) hours, requiring prolonged anesthesia for the patient.Concomitant devices: nail (part unknown, lot unknown, quantity 1), guide wire (part unknown, lot unknown, quantity 1), drill guide (part unknown, lot unknown, quantity 1).

• Brand Name: REAMER Ø11 F/PFNA BLADE
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8048521
• MDR Text Key: 126501981
• Report Number: 8030965-2018-58023
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819326958
• UDI-Public: (01)07611819326958
• Combination Product (y/n): N
• 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: 10/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.821
• Device Lot Number: U200200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 12/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention