MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM

Catalog Number 338.000

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

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent a hip fracture surgery on (b)(6) 2017.During the procedure, the patient was affected because the guide wire was broken inside the patient, generating a lot of bleeding and the surgery was extended by more than 4 hours.The surgical delay was due to removal of the guide wire fragments.The doctor managed to remove the guide wire satisfactorily.The doctor indicates that when he was drilling the guide wire, the guide wire twisted in the patient bone and broke off.Patient outcome reported as ok, but lost a lot of blood.Concomitant device reported: drill (part # unknown, lot # unknown, quantity 1).This report is for one (1) 2.5mm dhs/dcs guide wire w/threaded tip 230mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Date returned to manufacturer corrected.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

Product complaint #(b)(4).Investigation summary: it was reported to the quality department by a surgical support agent that an adverse event in which the patient was affected because the guide wire was broken inside the patient, generating a lot of bleeding and the surgery was extended by more than 4 hours.The doctor managed to remove the guide wire satisfactorily.The doctor indicates that when he was drilling the guide wire, the guide wire twisted in the patient bone and broke off.Cq (ous) investigation: 1 x 338.000 dhs/dcs-guidewire ø2.5 w/thread-tip w/tr / lot 9808636 - as received condition: the dhs/dcs-guide-wire broke into two pieces: the investigation has shown that the dhs/dcs-guide wire is broken into two pieces, both fragments were returned.In addition, the guide-wire shows strong damages all over the part and is also strongly twisted.A device history record review was performed and the review shows that there were no issues during the manufacturing of the product that would contribute to this complaint condition.No ncr¿s were generated during production of work order (b)(4) for the material (b)(4) (505 pcs) and work order (b)(4) (503 pcs.) which is related to the finish good product part number 338.000 / lot number 9808636.The relevant length cannot be measured due to its broken off damaged condition.The investigation found no manufacturing related issues that would have contributed to this complaint condition.The exact cause of failure cannot be determined; a material or manufacturing related issue can be excluded.Conclusion: a device history record (dhr) review, device inspection, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.The complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.The investigation found no manufacturing related issues that would have contributed to this complaint condition.The lot went through the required steps during the inspection at the time of manufacturing and the dhr records showed no issues concerning the material or material conditioning.Based on the date of manufacture, reflecting the current and manufactured drawing revision, was reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The diameter of the device was inspected and found within the specification.A review of risk assessment found that it covered the returned guide wire.There is no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot - part no.: 338.000, lot no.: 9808636, manufacturing location: (b)(4), release to warehouse date: 20.Jan.2016.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.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: 2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM
• Type of Device: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7128731
• MDR Text Key: 95220656
• Report Number: 8030965-2017-50826
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819021907
• UDI-Public: (01)07611819021907(10)9808636
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.000
• Device Lot Number: 9808636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR