MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 100MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.400S

Device Problem Unintended Movement (3026)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Date of event is unknown.Additional classification code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Telephone information unknown.A device history record review was requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 revision proximal femoral nail (tfna) - blade cut out occurred on (b)(6) 2018, by dr (b)(6) at (b)(6) hospital.Primary operation date was (b)(6) 2018 - surgeon (b)(6); surgeon attributed cut out of blade in head due to poor original position in femoral head and poor-reduction of proximal femur fracture.Noted that it was a very difficult primary reduction.First revision occurred on (b)(6) 2018; patient underwent further reduction of fracture with implantation of x2 cables (informed on (b)(6) 2018 at time of revision surgery).Second revision occurred on (b)(6) 2018; successful revision surgery completed.The surgeon pleased with new position of blade in femoral head and modified coronal plane reduction.Implants explanted and discarded - due to loss of reduction and superior blade cut out in femoral head.Implanted during revision proximal femoral nail surgery on (b)(6) 2018: 04.037.234s x1 - tfna fem nail 125 degree x 12 mm x 440 mm, the 04.038.400s x1 - tfna blade 100 mm.The 04.005.542s x1 - 5.0 locking bolt, 52 mm the 04.005.550s x1 - 5.0 locking bolt, 60 mm.Concomitant parts reported: 1x 04.037.464s lot.9805312, 1x 04.005.550s lot.9778840, 1x 04.005.546s lot.9659805, 1x 04.005.542s lot.L454740.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Dhr review was completed.Part number: 04.038.400s, lot number: h338348, date of manufacture: 17 may 2017, place of manufacture: (b)(4), part expiration date: 01 may 2027, nonconformance noted: (b)(4).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 but there was a nonconformance noted, (b)(4).This nr was for scrapping 123 lbs of the 395 lb lot of raw material received for a bent bar straightness non-conformance.This nonconformance had no effect on the complaint as the nonconforming bars would not feed into the production machine.The remaining 272 lbs of this raw material lot conformed and was accepted.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.Customer quality conducted an investigation based on x-rays provided.Complaint is confirmed as we are able to confirm complaint description based on the received pictures.The manufacturing documents were reviewed and no complaint related issues were found.Product was not returned, therefore no further investigation is possible.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Date reported in mwr-(b)(4) was 3/6/2018.Correct date should have been 3/5/2018.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: TFNA FENESTRATED HELICAL BLADE 100MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7392104
• MDR Text Key: 104174118
• Report Number: 8030965-2018-52704
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652590
• UDI-Public: (01)07611819652590(17)20270501(10)H338348
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.400S
• Device Lot Number: H338348
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention