MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE PERF L100 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.400S

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Implant date is unknown.Explant date is unknown.Date of product received is currently unknown.(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.A device history record review has been requested.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 surgery that during surgery, it was not possible to easily insert the blade.When taking a new blade for the same nail, the blade insertion was very easy possible.There was approximate a 30 minute surgical delay.Concomitant reported part: unknown tfna nail.(b)(4).

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.

Manufacturer Narrative

Additional device product code: ktt.A device history record (dhr) review was performed part number: 04.038.400s, lot number: h168654: date of manufacture: 06 september 2016, place of manufacture: (b)(4), part expiration date: 01 august 2026, nonconformance noted: n/a: description of dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 100mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A product investigation was performed.It was reported that during surgery there was no easy blade inserting possible.This complaint was not able to be confirmed at customer quality.No visual evidence of complaint event was provided and the nail and instrument construct was not returned with the helical blade and therefore the complaint could not be functionally replicated.Visual examination of the returned helical blade revealed wear marks consistent with attempted insertion and subsequent removal.Two deep gouges exist on the blade.The wear pattern of one deep gouge suggests it occurred during removal.The other appears that it was created during insertion.It is most likely these gouges were created by contact with the already implanted nail, however this can not be definitively determined without further evidence.A functional test / replication of the complaint was not able to be performed because the nail was not returned with the helical blade.Tabulated drawing for the family of titanium tfna fenestrated helical blades was reviewed during this investigation.No product design issues or discrepancies were observed.The outside diameter of the returned helical blade in areas without post manufacturing damage was measured at cq and found to be within specification per tabulated drawing.The outside diameter to flat dimension of the returned helical blade in areas without post manufacturing damage was measured at cq and found to be within specification per tabulated drawing.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.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.Device is a single use device but was not reprocessed or reused.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA HELICAL BLADE PERF L100 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7112685
• MDR Text Key: 95399405
• Report Number: 8030965-2017-50590
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652590
• UDI-Public: (01)07611819652590(17)260801(10)H168654
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K160167
• 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: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.400S
• Device Lot Number: H168654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1