MAUDE Adverse Event Report: SYNTHES (USA); EXTRACTOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Event date unknown number 510k: 1 unknown trauma (distal tibia set) /unknown lot.Part and lot number are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.Telephone number unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).The customer had difficulty to remove a biomet tibial plate.The synthes distal tibial set was unable to remove it.It is not known if the operace have been used to attempt to remove the plate and screws.To remove the implants the surgeon requested the wrong instrumentation set.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 the customer had difficulty to remove a biomet tibial plate.The synthes distal tibial set was unable to remove it.It is not known if the operace have been used to attempt to remove the plate and screws.The surgery may have had to be rescheduled.A revision surgery was performed because the screws were too long.To remove the implants the surgeon requested the wrong instrumentation set.The implants are still implanted.Revision surgery will be performed in another hospital.Concomitant reported parts: 1x screwdriver insert for hexagonal socket (part 80048 lot unknown).1x unknown biomet plate.Unknown screws (3.5 and 4.0 titanium).This report is for 1 unknown trauma (distal tibia set).This report is 1 of 1 for (b)(4).

• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6901125
• MDR Text Key: 87653446
• Report Number: 2520274-2017-12356
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 QTY, UNKNOWN BIOMET PLATE; 1 QTY, PART 80048, LOT UNKNOWN; UNKNOWN QUANTITY OF UNKNOWN SCREWS (3.5 AND 4.0 TI
• Patient Outcome(s): Required Intervention