MAUDE Adverse Event Report: SYNTHES GMBH UNK - REAMERS

Device Problem Entrapment of Device (1212)

Patient Problems Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559)

Event Type  Injury  

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.This report is for an unknown reamer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.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

It was reported that the patient underwent an open reduction/internal fixation procedure on or about (b)(6) 2018.Prior to the surgery, the surgeon told the patient and her husband that he needed a small reamer, but he did not have such a small reamer for the surgery, and this led to complications.The reamer he used got stuck or entrapped in the patient¿s humerus and had to be removed by way of multiple traumatic procedures and incisions.The patient sustained the following injuries and damages: pain and permanent neurological deficits, nerve damage to the left extremity, loss of motion and strength in the left extremity, and pain in the upper left extremity.She also had bone grafts taken from her leg as a result.This report involves one unk - reamers: trauma.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - REAMERS
• Type of Device: REAMER
• 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: 15528891
• MDR Text Key: 301027190
• Report Number: 8030965-2022-07713
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/03/2022
• 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 Sex: Female