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

Catalog Number UNK - EXTRACTION INSTRUMENTS:

Device Problems Device Damaged by Another Device (2915); Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).This report is for an unknown : extraction instruments trauma/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary: 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 a novelty in (b)(4), the dr.States that it was not possible to remove the nail due to the poor condition of the instruments so he was forced to finish the procedure and schedule a new intervention, requesting that the instruments be delivered complete as if the patient were to be implanted for the first time and also send tns extraction, the doctor said that this same situation happened to him in 2018.Second procedure scheduled for (b)(6) with collective (b)(4).Concomitant device reported: unknown nail (part #: unknown, lot #: unknown, quantity #: 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: UNK - EXTRACTION INSTRUMENTS: TRAUMA
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9578452
• MDR Text Key: 189177419
• Report Number: 8030965-2020-00267
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

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
• Device Catalogue Number: UNK - EXTRACTION INSTRUMENTS:
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/06/2020
• Patient Sequence Number: 1
• Treatment: UNK - NAILS
• Patient Outcome(s): Required Intervention