MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 03.010.405

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id: (b)(6).Patient age not provided for reporting.Device is an instrument and is not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device 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 on an event in (b)(6) as follows: it was reported that the removal of the proximal femoral antirotation nail (pfna) from the connecting screw was not possible.The surgery was delayed about 60 minutes.Devices had to be removed.Surgery was completed with new products.Surgery took four hours.This report is 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.Part number: 03.010.405.Synthes lot number: 8365826.Release to warehouse date: 20.June 2013.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.Customer quality conducted an investigation of the returned device.Investigation selection.Investigation site: cq zuchwil.Selected flow: 2.Device interaction/functional.Visual inspection: the returned pfna nail was tightened with the connecting screw on the insertion handle.No abnormal findings were identified on these returned parts.All in all the parts are in used condition.Function test: the returned assembled pfna nail on the insertion handle could be dissolved without high effort.With the screwdriver (art.03.023.011) could dissolved the connecting screw (art.357.029).Summary: the received condition of these parts are concordant with the complaint description and the complaint condition is unconfirmed.With the screwdriver (art.03.023.011) could dissolved the connecting screw (art.357.029).No abnormal findings were identified on these returned parts.All in all the parts are in used condition.Based on that and the condition of the parts a product related issue can be excluded.Unfortunately the exact cause which has led to the occurence could not be evaluated.We only can assume that a mechanical overloading situation, for example strongly tighten during assembling the construct, has caused the stuck connection 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.

Event Description

Concomitnat device reported: pfna blade (04.027.036s, lot l700651, quantity 1).

• Brand Name: RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7535544
• MDR Text Key: 108992607
• Report Number: 8030965-2018-53925
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819349421
• UDI-Public: (01)07611819349421
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.405
• Device Lot Number: 8365826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 80