MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS BLADE Ø12.5 L85 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.224.085S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown due to intra-operative issues, the device as not implanted/explanted.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during an open reduction internal fixation (orif) procedure on (b)(6) 2018 there was an issue with the dynamic hip system (dhs) blade.When the 85mm dhs blade was prepared, it was found that the tip of the blade was immobile.Even when the locking mechanism was released, the tip was still immobile; the shaft part and the blade part did not rotate each other.A 90mm dhs blade was inserted instead.During that insertion, the surgeon hammered the blade and the tip of the inserter broke off.The fragment was removed, and the surgery was completed within a thirty (30) minute delay.The dhs plate was fully seated after the 90mm blade was implanted.There was no adverse consequence to the patient.Patient outcome is stable.Procedure was successfully completed.This is report 1 of 2 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.A device history record (dhr) review was conducted for part no.: 04.224.085s, lot no.: l428317: manufacturing location: grenchen, release to warehouse date: 22.May.2017, expiry date: 01.May.2027: no non-conformance reports (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.A product investigation was conducted.Visual inspection: the blade was received in a non-synthes bag.The surface of the blade has not visible damages or scratches in its surface.Its laser marking is completely readable.Function test: the returned blade was tested and the complaint condition could be confirmed, as it is not rotatable.Dimensional inspection: a measurement of the rotational components is not possible without destroy the blade.According to the information requested to the project design team, there is a built-in snap ring which has the function of preventing disassembly.To perform further analysis/measurements in the components relevant to the function; a destructive test authorization was requested in order to disassemble the blade since this one can be only dissembled destroying it.The main purpose of the destruction was to disassemble the blade to inspect its components.Thus, the relevant features for the function of the shaft and blade were measured and the main conclusion is that the results are according to the manufacturing specifications.Document/ specification review: a dhr review was performed for the affected lot l428317 / product code 04.224.085s.This article is composed by 5 components besides, 4 of these components were manufactured by the supplier ypsotec ag.Only the component 524525 was manufactured by synthes grenchen.During the ¿external process step¿ the functional inspection was performed by the supplier früh according to the work instruction.In this step, früh has opened non-conformance due to the assembling issue ¿not rotatable after assembly¿.After the pieces were received at depuy synthes were scrapped.Summary: our investigation has shown that the complaint condition is confirmed.We have forwarded the received devices to the responsible manufacturing site for further evaluation with the following results: all dimensions relevant for the function of the product were measured, and do fulfill the specifications.The function of the blade in question was tested 100% before left our facility.We do suppose, that the inner locking screw was screwed very tight so that the blade remained blocked.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformances.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: DHS BLADE Ø12.5 L85 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7494289
• MDR Text Key: 107591039
• Report Number: 8030965-2018-53613
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819795495
• UDI-Public: (01)07611819795495
• 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
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.224.085S
• Device Lot Number: L428317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention