MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - EXTRACTION INSTRUMENTS: TRAUMA; EXTRACTOR

Device Problem Break (1069)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown extraction instrument/unknown lot.Part and lot number are unknown; udi number is unknown.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.Product was not returned.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, a patient with a femoral neck system (fns) was treated with a hip replacement.The hip replacement was not related to the implanted femoral neck system.During the procedure, the surgeon tried to remove the fns, but it was impossible to loosen the screw from the implant.The surgeon tried to remove the screw with an extraction tool, but the tool broke off in the screw head.After this, it was not possible to drill the screw out with an operace drill.The surgeon removed the whole implant with some cortical damage to the bone which did not result in any critical damage to the patient since the bone had to be removed and was covered by the total hip replacement.Procedure was completed with a delay of thirty (30) minutes.Patient status was good.This report is for an unknown extraction instrument.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - EXTRACTION INSTRUMENTS: TRAUMA
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10575585
• MDR Text Key: 208312188
• Report Number: 8030965-2020-07373
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2020

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: 09/02/2020
• Initial Date FDA Received: 09/23/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR