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

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown extraction instrument/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 reports an event in (b)(6) as follows: it was reported that during an previous unknown surgery on an unknown date the surgeon was not able to adequately remove the screw in the dhs system in the femoral neck component.Surgeon commented that the screwdriver was of the incorrect size.No further information is provided.This report captures the previous incident which also involves an extraction instrument that was not able to adequately remove the screw while related complaint (b)(4) captures the current incident which involves a a connecting screw for extraction dhs blade that was not able to adequately remove the screw in the dhs system in the femoral neck component.This report is for one (1) unknown extraction instrument.This is report 1 of 3 for complaint (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: 9519670
• MDR Text Key: 188686163
• Report Number: 8030965-2019-71457
• 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: Physician
• Type of Report: Initial
• Report Date: 12/09/2019

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: 12/09/2019
• Initial Date FDA Received: 12/26/2019
• 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