MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH END-CAP F/A2FN CANN EXTENS. 0 TAN GREY; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.009.000S

Device Problems Failure To Adhere Or Bond (1031); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.Patient code (b)(4) is used to capture the surgical intervention: the incision was enlarged and unknown bone wax was applied to the nail instead of an end cap, and the surgery was completed with a 30-minute delay.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 (b)(4) reports an event in (b)(6) as follows: it was reported that a surgery for femoral diaphyseal fracture was performed on (b)(6) 2017.After the nail and some screws were inserted, the surgeon could not fix the end cap 10mm to the nail.In addition to the main surgeon, three other surgeons took turns to correct this difficulty with the following countermeasures, which did not succeed: repositioning of the patient¿s body, enlarging the incision area, lightly hitting to the driver for inserting end cap with a hammer, replacing with end cap 5mm and end cap 0mm.Finally, unknown bone wax was applied to the nail instead of an end cap, and the surgery was completed with a 30-minute delay.There was no adverse consequence to the teenage patient.The surgeon commented that hammering might have damaged threads of the nail.Procedure was completed successfully.Concomitant device reported: unknown hammer/mallet (part # unknown, lot # unknown, quantity 1) this report is for one (1) end-cap f/a2fn cann extens.0 tan grey.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: dhr review was completed.Part number: 04.009.000s synthes lot number: l346995 release to warehouse date: 19.Apr.2017 expiry date: 01.Apr.2027 manufacturing site: (b)(4).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.Dhr customer quality conducted an investigation of the returned device.Part was sent to manufacturing site for investigation.As received condition of device: the part (lot l346995) has been returned not in original packaging.There are not visible damages on the surface.Information etched on product matches to complaint system and dhr.Dhr review: lot l346995 was manufactured in april 2017 in (b)(4).All the inspections performed according to inspection sheet passed.No ncrs were generated.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Lot l346995 was manufactured starting from raw material lot 19708.The certificate of the raw material lot 19708 has been reviewed.In the relative certificate, it is reported that the material is conforming.Product inspection: the part (lot l346995) was inspected for all the features pertinent to the complaint condition according to the product investigation matrix ¿does not fit with other parts¿ reported in the procedure.All the measurable features pertinent to complaint condition have been found conforming to specification.The thread m8x0.75-6g is visually damaged post production for this reason is not measurable.No evidence of nonconformance manufacturing related.The raw material has been verified through review of certificate documented in the dhr review section.Conclusion: considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned items, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.Disposition: the manufacturing investigation is disposed as confirmed due the fact that the thread is visually damaged.The manufacturing investigation is considered not valid for (b)(4) because there is no evidence of issues manufacturing related and only the end cap item was returned and it was found conforming to specification.The coupling with the nail could not be verified due to the fact that the nail was not returned.No manufacturing related issue was identified, dcrm investigation shows that the complaint is adequately addressed by the risk assessment.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

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: END-CAP F/A2FN CANN EXTENS. 0 TAN GREY
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7165880
• MDR Text Key: 96444361
• Report Number: 8030965-2018-50082
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819323582
• UDI-Public: (01)07611819323582(17)270401(10)L346995
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.009.000S
• Device Lot Number: L346995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention