MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDEWIRE Ø3.2 F/PFNA BLADE

Catalog Number 356.830S

Device Problem Dull, Blunt (2407)

Patient Problem Not Applicable (3189)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The wire penetrated the bone head during insertion of the blade.Investigation summary: 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, 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.

Event Description

It was reported that on (b)(6) 2018, a guide wire was used in the pfna/orif (proximal femural nail antirotation / open reduction internal fixation) surgery for femoral trochanteric fracture (right).During the surgery the guide wire was inserted after the nail was inserted.Clashing sound was heard when using a reamer after measurement was completed.Blade was inserted, but the insertion was incomplete.As he tried to insert the blade using a hammer, the guide wire penetrated the bone head part.The surgeon replaced the guide wire with a new one.The surgery was successfully completed with no delay, and there was no adverse consequence to the patient.This report is for two (2) devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Added concomitant devices.A device history record (dhr) review was performed: please note, this dhr review is for sterilization procedure only: part no.: 356.830s, lot no.: l675910: manufacturing location: (b)(4), supplier: (b)(4), release to warehouse date: 29.Nov.2017, expiry date: 01.Nov.2027, 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.Non-sterile 356.830, l617486 was manufactured in (b)(4), release to warehouse date: 15.Nov.2017: 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.Corrected data: device is an instrument and is not implanted/ explanted.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

Concomitant devices reported: guides/sleeves/aiming: aiming arm (part # unknown, lot # unknown, quantity 1); nail insertion handles (part # unknown, lot # unknown, quantity 1); nails (part # unknown, lot # unknown, quantity 1); insertion inst: coupling screw (part # unknown, lot # unknown, quantity 1); protection sleeve (part # unknown, lot # unknown, quantity 1); nuts (part # unknown, lot # unknown, quantity unknown).

• Brand Name: GUIDEWIRE Ø3.2 F/PFNA BLADE
• Type of Device: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7392977
• MDR Text Key: 104248761
• Report Number: 8030965-2018-52710
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819898073
• UDI-Public: (01)07611819898073(17)271101(10)L675910
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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
• 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: 356.830S
• Device Lot Number: L675910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Date Device Manufactured: 11/29/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR