MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS: MULTILOC HUMERAL NAIL; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - end caps: multiloc humeral nail/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.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, the patient underwent surgery for surgical neck fracture of right humerus with a multiloc proximal humeral nail.After surgery, it was found that the patient became unable to raise his/her own wrist.The surgeon considers that there is a possibility that the radial nerve was damaged during the locking screw insertion or has been pinched by the screw head because there is no sign of improvement after 2 weeks of follow-up.Depending on the future course, removal of the locking screws will also be planned and the patient has dementia.This report is for one (1) unk - end caps: multiloc humer.This is report 4 of 4 for complaint (b)(4).

• Brand Name: UNK - END CAPS: MULTILOC HUMERAL NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13203850
• MDR Text Key: 283480664
• Report Number: 8030965-2022-00196
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• 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
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; UNK - END CAPS: MULTILOC HUMERAL NAIL
• Patient Outcome(s): Required Intervention