MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD, FIXATION, INTRAMEDULLARY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.This report is for unknown nail head elements: pfna /unknown lot number.Udi is unavailable.Device malfunctioned intra-operatively and was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: product was not returned and no article- and lot number was provided.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.

Event Description

Device report from synthes on an event in (b)(6) as follows: 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 2 of 2 for (b)(4).

Manufacturer Narrative

Added concomitant devices.As specific part and lot numbers for pfna blade is not provided.Corrected data: this report is for one (1) unknown pfna blade/ lot number unknown.Without the specific part and lot number the udi number is not available.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); nail (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).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA ; SZ ; 6107195000
• MDR Report Key: 7392975
• MDR Text Key: 104428215
• Report Number: 8030965-2018-52712
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• 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 Age: 88 YR