MAUDE Adverse Event Report: SYNTHES GMBH UNK - EXTRACTION INSTRUMENTS: HIP EXTRACTION; EXTRACTOR

Catalog Number UNK - EXTRACTION INSTRUMENTS:

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/14/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional 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 expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter is a j&j employee.(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: incorrect delivery of intramedullary nail extraction material in the femur with patient involvement because he was anesthetized and the surgery could not be performed.This complaint involves one (1) device unk - extraction instruments: hip extraction.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a2, b5.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

Updated: it was reported that a patient underwent the removal of an osteosynthesis material (intramedullary nail) for which a special johnson screwdriver was essential.In the checklist made by the instrumentalist, it was confirmed that she had the complete materials to perform the procedure.The patient received general and regional anesthesia and when the surgery began, they realized that the screwdriver they needed to release the intramedullary nail was not in the set.They did not have a contingency plan to request this material and the surgery could not be performed, with the patient under anesthesia and with the surgical incisions already made.Procedure was postponed as removal procedure could not be completed.

• Brand Name: UNK - EXTRACTION INSTRUMENTS: HIP EXTRACTION
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14085431
• MDR Text Key: 289177179
• Report Number: 8030965-2022-02377
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23 YR