MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L80 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.051S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Date of event is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Reporter email address is unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.(b)(4).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 japanese pfna compression blade in question was used for femoral surgery on an unknown date.After inserting the blade, the surgeon failed in its locking by normal clockwise turns.The surgery was completed with a replacing blade in different size.There was no adverse consequence to the patient.The surgeon commented that he might have excessively turned counterclockwise when attaching the blade to an impactor.This report is for a pfna-ii blade l80 tan.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Patient ethnicity is unknown.Part: 04.027.051s; synthese lot: l579291; release to warehouse date: september 21, 2017; expiry date: september 01, 2027; manufacturing site: bettlach; no nonconformance 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.Investigation site: cq zuchwil; selected flow(s): 2 device interaction/functional visual inspection: the received part is badly damaged by the user.The inner sleeve was turned in incorrect position.The locking screw was turned in far too much as described in complaint event description.As result of the complete wrong position of those components, it was not possible to lock the system as intended anymore.Functional test: it was not possible to remove the locking system (locking screw was too deep into the sleeve) from its incorrect position.The system is completely blocked in itself and parts cannot be moved anymore.The complaint cannot be replicated as it is not possible to perform any functional test but the complaint condition can be confirmed as it is not possible to lock the system as result of excessive applied force during use.As it is not possible to disassemble the system and as result of the damages, no dimensional checks can be done.Design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition.The complaint is adequately addressed by the risk assessment.No product fault could be 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: PFNA-II BLADE L80 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7552929
• MDR Text Key: 109693199
• Report Number: 8030965-2018-54037
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394209
• UDI-Public: (01)07611819394209
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.051S
• Device Lot Number: L579291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention