MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; SCREW, FIXATION, BONE

Catalog Number 04.005.414S

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

Patient Problem Neuropathy (1983)

Event Date 04/06/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent the surgery using mhn left short nail for proximal end of humerous fracture with the screws in question.The surgery was completed successfully without any surgical delay.After the surgery, it was confirmed on (b)(6) 2022, during a meeting between the sales rep and the surgeon that patient developed radial neuropathy.There is no plan for re-operation at this point, and the patient have been continuing to be followed up with a brace on the affected area.The surgeon has thought that the screws are stimulating the nerve.No further information is available.This report is for one (1) lockscr ø4 l24 f/nails tan dblue.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: additional device product codes: hsb.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: LOCKSCR Ø4 L24 F/NAILS TAN DBLUE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14347344
• MDR Text Key: 291306877
• Report Number: 8030965-2022-03087
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.414S
• Device Lot Number: 600P701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø4 L24 F/NAILS TAN DBLUE